a4f:l COVIDIEN
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1. whether the audible backup alarm would function properly in the event of total power loss How to conduct this test is clearly outlined in the attached Service Manual Addendum Covidien will provide an initial inventory of PCBs to support the results of testing conducted during preventive maintenance If testing determines that the PCB needs to be replaced please place the tested PCB in the shipping container of the replacement PCB complete the included documentation and labels package the replaced PCB in the shipping container of the replacement PCB and return it to Covidien at the address provided Upon receipt of the tested PCBs Covidien will dispatch to you new or refurbished PCBs equal in number to those returned for use in subsequent board replacements This procedure will cover one 1 PCB per 6135 GUNBARREL AVENUE 800 635 5267 T BOULDER CO 80301 USA Legendair and for a period not exceeding one 1 calendar year from the date of reception of this letter PCBs returned to Covidien that are found to pass the screening test or are faulty for reasons not related to the alarm test specified will not be eligible for replacement under this procedure If results of testing do not indicate the PCB needs to be replaced no further action is required Until the scheduled preventive maintenance has been completed the ventilator must be operated primarily under mains power and with a fully charged internal battery as currently2. Ea COVIDIEN MEDICAL DEVICE FIELD SAFETY NOTICE LEGENDAIR Veatilator May XX 2011 Dear Valued Customer This letter is to inform you of a field safety notice on the LEGENDAIR ventilator related to potential failure of audible backup alarms in the event of power loss to the ventilator Codes for affected products are referenced below 4095700 INTL LEGENDAIR SINGLE BRANCH X1 4095701 GB NO LEGENDAIR SINGLE BRANCHX1 4095702 DE LEGENDAIR SINGLE BRANCH X1 4095705 CA LEGENDAIR SINGLE BRANCH X1 JP LEGENDAIR SINGLE BRANCH X1 4095709 DK LEGENDAIR SINGLE BRANCH X1 4095906 JP LEGENDAIR DOUBLE BRANCH X1 4095909 DK LEGENDAIR DOUBLE BRANCH X1 4095921 AU LEGENDAIR DOUBLE BRANCH X1 We have found that a capacitor in the Central Processing Unit CPU printed circuit board PCB used on the Legendair to power the backup battery alarm in the case of loss of power may degrade This could lead to a decreased time of audible sound less audible or no audible alarm at all in the event of power loss to the ventilator Current information indicates the lifetime of these capacitors may be affected by usage temperature Investigation is continuing to further define the details of the capacitor life According to our records you have a ventilator which may be impacted by this issue During the next scheduled preventive maintenance cycle an additional test of the ventilator must be conducted This will determine
3. specified in the Service and Operators Manual if you do not currently conduct your own preventive maintenance please contact your maintenance provider to inform them of this update or your local Covidien Service Center at the number provided attached This notice is being distributed with the knowledge of appropriate regulatory authorities We sincerely apologize for any inconvenience this may cause and appreciate your attention to this matter Sincerely Frances E Harrison Vice President Regulatory Affairs Respiratory and Monitoring Solutions Covidien formerly known as Tyco Healthcare Attachment Manual Addendum 6135 GUNPARREL AVENUE 800 635 5267 rT BOULDER CO 80301 USA al COVIDIEN Date 11 05 2011 Maintenance File Revision B Addendum Legendair Portable Ventilator Involuntary Stop Alarm Test The following test should be performed during your annual service to ensure the performance of the audio alarm when all power is lost or a complete failure of the system and software e Switch the device on using the mains switch at the rear e Connect a patient circuit and test lung e Start the ventilation e Leave unit to ventilate for a minimum of 10 minutes e Set the AC mains switch to the off position e The device will turn off and the alarm should be active e Confirm that the alarm sounds for at least 15 seconds e Set the mains switch to the on position e Then stop ventilation with the O key b
4. y pressing and holding for 3 seconds and then releasing the key when prompted on the screen Kind regards Frances E Harrison Vice President Regulatory Affairs Respiratory and Monitoring Solutions Covidien formerly known as Tyco Healthcare Page 1of1 C OVI DI E N Please insert date the form was sent URGENT MEDICAL DEVICE FSCA L gendair ventilators VERIFICATION FORM Customer Contact Details Covidien Contact Details Hospital Name Telephone n Please test all devices and complete attached forms as indicated below To please insert name Covidien commercial office Address please insert Covidien address Telephone n please insert Covidien telephone number Option 1 The alarm functions correctly and sounds for 15 seconds Please complete form 1 Option 2 The alarm function does not sound or sounds less than 15 seconds Please complete form 2 Name Signature Date please print The alarm sounds for 15 seconds FORM 1 Please fax the form back to enter fax number Date Device Tested Service Engineer NAME L gendair Serial number The alarms doesn t sound or sounds for less FORM 2 than 15 seconds Please return the device to enter address L gendair Serial number PCB serial number Service Engineer NAME Date of Replacement New PCB Serial Number iDate Old PCB Returned
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