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URGENT FIELD SAFETY NOTICE
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1. GE 3 OF 9 URGENT FIELD SAFETY NOTICE Attachment Il Oxygen Sensor Maintenance and Alarms for the Puritan Bennett 840 Ventilator Puritan Bennett 800 Series Ventilator System Operator s and Technical Reference Manual Operator preventive maintenance procedures and frequency Pages OP 7 11 OP 7 12 PREVENTIVE MAINTENANCE PREVENTIVE MAINTANCE REFERENCE SCHEDULE PART MAINTENANCE SOURCE FREQUENCY Daily or as necessary Oxygen sensor Press the 100 O2CAL2MIN Puritan Bennett 800 key or INCREASE Oz 2 min key to calibrate Series Ventilator System the oxygen sensor Refer to Appendix D in this Operator s and manual to test the oxygen sensor calibration Technical Reference Manual Puritan Bennett 800 Series Ventilator System Operator s and Technical Reference Manual Alarm Summary Table 13 2 Base message Urgency Analysis message Remedy message Comments Oz sensor Ventilation unaffected O sensor out of Background checks calibration failure have detected a Press 100 O CAL problem Resets when or INCREASE O22 joperator successfully calibrates oxygen sensor or disables oxygen sensor Puritan Bennett 800 Series Ventilator System Operator s and Technical Reference Manual Alarm Messages Pages OP 5 13 OP5 15 WHEN YOU SEE IT MEANS DO THIS THIS MESSAGE Low delivered 02 The 02 measured during any Check the patient the air and oxygen phase of breath cycle is 7 12 supplies the oxygen analy
2. URGENT FIELD SAFETY NOTICE E COVIDIEN Covidien Deutschland GmbH Gewerbepark 1_ D 93333 Neustadt Donau FSCA Reference O2 sensor label update 01 14 Oxygen sensor instructions for the Puritan Bennett 840 ventilator and Puritan Bennett 700 series 740 and 760 ventilators Dear Covidien Customer Covidien is conducting a voluntary field correction with updated labeling to clarify the operational life of the oxygen sensor O sensor P N 4 072214 00 used in the Puritan Bennett 840 ventilator P N G 062010 00 used in the Puritan Bennett 700 series ventilators Puritan Bennett 740 and 760 ventilators and PN G 062009 00 O2 sensor kit used with either the Puritan Bennett 840 ventilator or the Puritan Bennett 700 series ventilators The oxygen sensor for the ventilators has a life of one year from date of manufacture of the sensor depending on the operating conditions Conflicting information was provided to Puritan Bennett 840 ventilator customers in a labeling addendum P N 066009A 09 02 stating that the oxygen sensor should be replaced every two years The correct operational life is one year from the date of manufacture as stated in the Puritan Bennett 840 ventilator operator s manual The sensor P N 4 072214 00 amp sensor kit PN G 062009 00 should not be used after the expiration date printed on the oxygen sensor package The Puritan Bennett 700 series ventilator operator s and service manuals also state that the oxyge
3. f the Swissmedic If you have any questions about this letter or to report any issues with a Puritan Bennett ventilator contact your local Technical Support Department at 49 0 9445 959 380 or your Covidien representative to ensure proper device reporting procedures are followed We apologize for any inconvenience this may cause and thank you for your prompt attention to this matter Sincerely Alexander Walter Regulatory Affairs Manager DACH amp Norden Attachment Oxygen Sensor Operational Life Labeling Update for Puritan Bennett 840 Ventilator and Puritan Bennett 700 Series Ventilators Attachment II Oxygen Sensor Maintenance and Alarms for the Puritan Bennett 840 Ventilator Attachment III Oxygen Sensor Replacement for the Puritan Bennett 840 Ventilator Attachment IV Oxygen Sensor Maintenance and Alarms for Puritan Bennett 700 Series Ventilators COVIDIEN PAGE 2 OF 9 URGENT FIELD SAFETY NOTICE Attachment Oxygen Sensor Operational Life Labeling Update for the Puritan Bennett 840 and Puritan Bennett 700 Series 740 and 760 Ventilators Please note the following important operational life and installation information related to the oxygen sensors and ensure that all use and maintenance is performed by trained and qualified personnel Part Number P N 4 072214 00 Used with the P N 10097559 For use with the Puritan Puritan Bennett 840 ventilator Bennett 840 740 and 760 vent
4. ilators P N G 062010 00 Used with the Date Code E For this date code format MM YY For this date code format MM YY the Expiration Date 10 14 means that Install by 08 14 means that the sensor the sensor is no longer usable after must be installed in a ventilator before October 31 2014 In this example August 31 2014 It has one year of the sensor should not be installed or operational life from the installation date as used in a ventilator after this date long as it is installed before the date on the label In this example the sensor should not be installed or used after August 31 2015 Puritan Bennett 740 and 760 ventilators PN G 062009 00 O2 sensor kit used with either the Puritan Bennett 840 ventilator or the Puritan Bennett 700 series ventilators O Sensor The life of the Oz sensor is one year Once the sensor is installed the operational Life from date of manufacture depending life is 12 months if it is installed on or before on operating conditions the Install By date on the label Customer Ensure that maintenance logs for the ventilator contain information identifying when Maintenance the sensor needs to be replaced to ensure it is not used on a patient where the Information useful life may expire while in use Factors Sensor life depends on operating environment operation at higher temperature or affecting O gt high O levels can shorten the sensor life sensor Life COVIDIEN PA
5. important safety reminders should an O sensor alarms occur during use REFERENCE SOURCE PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM SERVICE MANUAL ALARM MESSAGES WHEN YOU SEE IT MEANS DO THIS THIS MESSAGE HIGH PRIORIT Y ALARM Measured Check air intake filter for O HIGH NO oxygen percentage more than 10 occlusion Replace if DIAGNOSTIC CODE percentage points above setting for at necessary LOGGED least 30 seconds Check oxygen supply Verify that an oxygen COVIDIEN PAGE 8 OF 9 WHEN YOU SEE IT MEANS THIS MESSAGE URGENT FIELD SAFETY NOTICE Auto reset when measured O2 is within 10 percentage points of setting HIGH PRIORITY ALARM Measured oxygen percentage more than 10 percentage points below setting for at least 30 seconds Auto reset when measured O2 is within 10 percentage points of setting The ventilator may have been calibrated at a high altitude then moved to a lower altitude DO THIS sensor is installed Check remaining sensor life via service summary and replace sensor if required Only a trained qualified individual should replace the sensor Perform FiO gt calibration check Replace pressure solenoid PCB Replacement of the solenoid should only be performed by a trained qualitied individual Check patient Check oxygen supply Verify than an oxygen sensor is installed Check remaining sensor life via service summary and replace sensor if requi
6. lowing this information will help ensure optimal operation of your ventilator e For the Puritan Bennett 840 ventilator only If you have addendum P N 066009A 09 02 remove and discard the addendum and replace it with the new information in Attachment I For the Puritan Bennett 740 and 760 ventilators only Please add the new information in Attachment to your current operator s manual and service manual e Please ensure all Os sensors in use or in inventory conform to the instructions in this notification Additional important information e If a sensor becomes nonfunctional during use and cannot be recalibrated an external oxygen monitoring device with oxygen alarm capability may be required to monitor the supplied level of oxygen from the ventilator and to provide appropriate alarms o A nonfunctional O sensor does not affect the concentration of oxygen delivered from the ventilator and does not control the flow of gases e f a sensor becomes nonfunctional and facility protocol requires transfer of a patient to an alternate ventilator the patient must be clinically evaluated to determine the best conditions for transfer to reduce risk to the patient e Ventilators are not intended to be a comprehensive monitoring device e Read and understand the warnings cautions and notes related to safety ventilator use and operation that are contained in the Preface of the Operator s Manuals This notification is being issued with the knowledge o
7. n sensor should be replaced every two years The sensor P N G 062010 00 amp sensor kit PN G 062009 00 should not be used after the expiration date printed on the oxygen sensor package The enclosed labeling update Attachment I provides detailed information related to the life of oxygen sensors used with the Puritan Bennett 840 740 and 760 ventilators This update supplements the information in the current Puritan Bennett 840 ventilator operator s manual and replaces information in the addendum to the Puritan Bennett 840 ventilator operator s manual and Puritan Bennett 700 series ventilator manuals To provide more options for sensor replacement Covidien has validated another oxygen sensor P N 10097559 for use in the Puritan Bennett 840 740 and 760 ventilators Information about that sensor is also included in the update in Attachment I COVIDIEN PAGE 1 OF 9 URGENT FIELD SAFETY NOTICE Attachment II Attachment III and Attachment IV include information about how to address O sensor alarms and managing situations where the sensor may become nonfunctional while these ventilators are in use Please be sure you understand the instructions for operating your ventilator and all precautions and warnings associated with its proper use Actions to be performed for this field safety notice e Read and understand the enclosed information and communicate this information to those who need to be aware of this labeling update Fol
8. red Only a trained qualified individual should replace the sensor O LOW NO Perform FiO calibration DIAGNOSTIC CODE check LOGGED Perform these HIGH PRIORITY ALARM Technical Alert Oxygen sensor missing or reading out of range calibrations O pressure calibration and then if applicable reg altitude calibration Replace pressure solenoid PCB Replacement of the solenoid should only be performed by a trained qualified individual Make sure an oxygen sensor is installed and securely connected to REPLACE O ventilator head harness SENSOR Alarm does not auto reset you must Perform FiO calibration DIAGNOSTIC CODE press alarm reset key check 6022 Replace oxygen sensor Only a trained qualified individual should replace the sensor
9. to the O sensor maintenance and alarms for the Puritan Bennett 700 series ventilators is described below Please refer to precautions and warnings in the operator s manual for proper use of the ventilators PURITAN BENNETT 700 SERIES VENTILATOR OPERATOR S MANUAL PREVENTIVE MAINTENANCE PREVENTIVE MAINTANCE SCHEDULE PART MAINTENANCE FREQUENCY Oxygen sensor Perform a calibration by selecting Calibrate Oz Sensor from the MENU oe key s Oxygen Sensor function g Ooo y OAY ee 0 ANY EOE O Sensor Allows you to perform a two point calibration of the oxygen sensor Only available before normal ventilation begins patient must not be connected NOTE Covidien recommends calibrating the oxygen sensor once a week or with each new patient 10066984 Section 6 Oxygen sensor O Alarm Info Allows you to enable or disable Table 6 1 Menu the oxygen sensor Functions Summary O Sensor Display Allows you to enable or disable displaying the oxygen sensor reading unless an alarm is active in the message window which is updated several times per second If the calibration is not successful contact service To continue ventilating if indicated by your institution s protocol disable the oxygen Oxygen sensor sensor select O alarm info from the Oxygen 10066984 Section 6 5 Sensor menu function Covidien recommends using an external oxygen monitor whenever the ventilator s oxygen sensor is disabled Please note the following
10. ventilator without O access port sensor access port Instructions for accessing oxygen sensor for the Puritan Bennett 840 ventilator with O access port 1 Locate the flexible oxygen sensor access cover onthe top edge of the cabinet Firmly push the center of the lower flap of the access cover until the lower flap is dislodged from the cabinet Pinch the bottom and top flaps of the access cover firmly together and pull the access cover away from the cabinet to remove the COVIDIEN PAGE 6 OF 9 URGENT FIELD SAFETY NOTICE Instructions for accessing the oxygen sensor for the Puritan Bennett 840 ventilator without O gt sensor access port Reference Puritan Bennett 840 System Service Manual If your BDU unit does not have an access port on the top right edge of the housing follow these instructions to replace the oxygen sensor Only a trained and qualified individual should replace the sensor 1 Remove the inspiratory module 2 Disconnect oxygen sensor harness from the sensor Be sure to press the wire retainer tab inside the recess of the oxygen sensor to release the connector 3 Unscrew oxygen sensor from PSOL manifold Please refer to the service manual for detailed instructions related to oxygen sensor replacement COVIDIEN PAGE 7 OF 9 URGENT FIELD SAFETY NOTICE Attachment IV Oxygen Sensor Maintenance and Alarms for Puritan Bennett 700 Series Ventilators Specific information related
11. zer and the during the first hour of operation ventilator or more below the O parameter for at least 30 Calibrate oxygen sensor press 100 seconds O CAL 2 min key See page TR 15 6 for The percentage window information on calibrating the oxygen increases by 5 for four minutes sensor after you increase the set O2 Use an external O monitor and disable value the Oz sensor COVIDIEN PAGE 4 OF 9 VID EN URGENT FIELD SAFETY NOTICE Background checks have detected a problem with the oxygen sensor sensor failure or it is out of calibration Patient ventilation is unaffected PAGE 5 OF 9 Press 100 O CAL or INCREASE O 2 min to recalibrate the oxygen sensor Disable the oxygen sensor Replace the oxygen sensor Only a trained qualified individual should replace the sensor URGENT FIELD SAFETY NOTICE Ed COVIDIEN Attachment Ill Oxygen Sensor Replacement for the Puritan Bennett 840 Ventilator There are two configurations of the Puritan Bennett 840 ventilator that influence the method required to change the oxygen sensor One configuration has an access port located along the top right edge of the breath delivery unit BDU cabinet that enables direct access to the oxygen sensor Please refer to the pictures below to identify your facility s configuration Only a trained and qualified individual should replace the sensor Puritan Bennett 840 ventilator with O Puritan Bennett 840
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