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1. have been informed Document name U Allgemein Technische Page 3of9 PE o Ciara and location Bulletins TB_009 TB_009_GB doc f 5 mee Created 2012 11 19 Released 30 11 2012 aa M Created by Markus Raab Released by Klaus Stemple Sba Vo 134082009 Safety information ff Technical Bulletin No 009 amp corpuls 8 Deadline Briefing the users should be effected immediately by appropriate measures e g via e mail or by posting this letter at the bulletin board and depositing a copy with the user manual Please return the filled in confirmation form Annex B to GS until December 20th 2012 at the latest The exchange will be carried out within 4 weeks after the return of the filled in confirmation form The implementation of this corrective action will have taken place until February 13th 2012 at the latest Document name U Allgemein Technische Page 40f9 geet Gar imarCart and location Bulletins TB_009 TB_009_GB doc fo gt Wy Created 2012 11 19 Released 30 11 2012 af QM Created by Markus Raab Released by Klaus Stemple Sanaa s20 sanaos Safety information Technical Bulletin No 009 cH corpuls 9 Contact person of the manufacturer for questions Carsten Fuchs Vice President Customer Support Head of Customer Support Tel 49 0 81 91 6 57 22 30 Fax 49 0 81 91 6 57 22 22 E Mail md vigilance corpuls com We thank you for understa
2. of one of the modules or of the compact device these incase of can be switched off individually by holding down the On Off key at the system crash respective module for 8 seconds Counting the seconds is recommended to make sure the button is held down for the correct amount of time It is not necessary to remove the battery A permanent correction of the error is only possible by installing a different software version 6 Immediate Measures Please ensure within your organisation that all users of the above mentioned products and all other persons who need to know are informed about this urgent safety information If you have supplied the products to third parties please forward a copy of this safety information to them and also inform the below mentioned contact person Please keep this information at least until the corrective measures have been completed 7 Corrective Measures of the Manufacturer This security information will be sent to all affected users until December 7th 2012 Maintenance for each device will be promptly arranged A different software version 1 9 0 or 2 0 3 will be installed to your device so you will soon have a fully operational device For the duration of the maintenance a replacement device will be supplied The Federal Institute for Drugs and Medical Products Das Bundesinstitut f r Arzneimittel und Medizinprodukte has received a copy of this safety information All affected national authorities
3. Safety information Technical Bulletin No 009 cH corpuls GS Elektromedizinische Ger te G Stemple GmbH Hauswiesenstra e 26 86916 Kaufering Germany Tel 49 8191 65722 0 Fax 49 8191 65722 22 info corpuls com www corpuls com No Target audience Date Number of pages 009 Affected users 30 11 2012 9 Affected products Serial numbers Lot identification Software Firmware corpuls No relation Software Version 2 0 0 and 2 0 2 Dear sir or madam with this letter we would like to inform you about the recall of software versions 2 0 0 and 2 0 2 that have been installed to a limited number of corpuls3 devices Due to a malfunction of the software the display on the monitoring unit may sporadically freeze and stop being operable after a diagnostic ECG has been started see User Manual chapter 6 3 The error manifests as extremely slow curve build up or lack of curves in the D ECG preview In this condition the device no longer reacts to keys being pressed We decided to recall all corpuls devices that are operating with the affected software version and to install a different software version According to our records your organisation has purchased at least one of the affected devices Please do read this safety information attentively and send back the filled in confirmation form attached in Annex B until December 20th 2012 So far we do not have information that other software versions for corpulls devices are a
4. ation Bulletins TB_009 TB_009_GB doc amp oY Created 2012 11 19 Released 30 11 2012 AA QM Created by Markus Raab Released by Klaus Stemple tanta Safety information Technical Bulletin No 009 5 corpuls Annex B Confirmation form Please mark with a cross ALL fields that apply to your company O We have read and understood the safety information of GS Elektromedizinische Ger te G Stemple GmbH of 2012 11 30 O We have informed our users in an appropriate way about the contents of this safety information and the amendment to the user manual O Weare attaching Annex D if necessary with corrected serial no of the affected devices in our company To be filled in by the customer please print Organisation Address Location Country Name First name Mr Ms Title Fax Phone organisation Company stamp E Mail address Date Signature Please return this confirmation form until 2012 12 20 at the latest to GS Elektromedizinische Gerate G Stemple GmbH Hauswiesenstrasse 26 D 86916 Kaufering fax 49 8191 65722 22 Or scanned as PDF attachment to md vigilance corpuls com Document name U Allgemein Technische Page 70f9 Poses anka and location Bulletins TB_009 TB_009_GB doc f certties Created 2012 11 19 Released 30 11 2012 aa M Created by Markus Raab Released by Klaus Stemple Scene so 13408 2009 Safety information Technical Bulleti
5. lso affected by this problem The responsible supervisory authorities of the involved countries and your local distributor have been informed about this FSCA Field Safety Corrective Action Document name U Allgemein Technische Page 1 of 9 geet itn and location Bulletins TB_009 TB_009_GB doc f 5 Wy Created 2012 11 19 Released 30 11 2012 a QM Created by Markus Raab Released by Klaus Stemple tania so 134052009 Safety information Technical Bulletin No 009 cH corpuls 1 Error description The software malfunction may cause a variety of sporadic not always reproducible errors in particular e Failure of the D ECG preview e possibly in combination with softkey failure e possibly in combination with defibrillator key failure 2 Prerequisite for the Occurrence of the Error One the software versions identified as problematic 2 0 0 or 2 0 2 is installed on your device You have started a D ECG preview and additionally e immediately prior to that you have changed the connection status see chapter 3 2 of the user manual and the new connection is not yet stable status display at the monitoring unit see table 4 2 of the User Manual you are changing the connection status when the device is in D ECG mode e you are entering data with the insurance card reader when the device is in D ECG mode you are performing an NIBP measurement at the same time 3 Potential Risk Diagnosis and the
6. n No 009 Annex C Authorised corpuls sales and service partners Please consult our homepage for international sales and service addresses www corpuls com S corpuls Document name U Allgemein Technische Page 8 of 9 TEC airea and location Bulletins TB_009 TB_009_GB doc amp 5 Wy Created 2012 11 19 Released 30 11 2012 AA QM Created by Markus Raab Released by Klaus Stemple tani po conan g P Safety information cS corpuls Technical Bulletin No 009 Annex D Serial numbers of corpuls3 that are affected in your company according to our records Serial numbers of devices affected Monitoring Unit Patient box Defibrillator Document name U Allgemein Technische Page 9 of 9 PUN ana and location Bulletins TB_009 TB_009_GB doc 5 Wy Created 2012 11 19 Released 30 11 2012 AA QM Created by Markus Raab Released by Klaus Stemple tani po conan
7. nding and apologise for any inconvenience you may have in connection with this corrective action Questions concerning this matter will be answered by your national sales and service partner see also Annex C or www corpuls com Kind regards GS Elektromedizinische Ger te G Stemple GmbH Gunter Stemple Klaus Stemple Managing Director General Manager R amp D Production Gesch ftsf hrer Gesch ftsf hrer F amp E Fertigung Document name U Allgemein Technische Page 5 of 9 pen Cirian and location Bulletins TB_009 TB_009_GB doc fo gt Wy Created 2012 11 19 Released 30 11 2012 a QM Created by Markus Raab Released by Klaus Stemple ce Gee so 134052003 Safety information Technical Bulletin No 009 Annex A Illustration of the device combination corpuls3 1 Monitoring Unit 2 Patient box 3 Defibrillator S corpuls 86916 Kaufering Made REF 04100 mozo CE A GS Elektromedizinische Gerite GmbH y in German Display Unit corpuls U 12VOC P2W U 12VOC P30W REF 04200 A Cem cs ische Ger te GmbH W 86916 Kaufering Made in Germany GS Elektromedizinische Ger te GmbH 85916 Kaufering Made in Germany Defib Unit copal Y 42 VDC IP 39w REF 04300 A i Wum lt y Rating plates with position of the serial numbers Document name U Allgemein Technische Page 6of9 Ora Cirian and loc
8. rapy are delayed because the measurement and therapy functions are not available until the monitoring unit has been re started 4 Safety information Please do notify your users as soon as possible about e possible malfunctions that can occur and relevant corrective measures If you want to record or send a D ECG with a device that has software version 2 0 0 or 2 0 2 installed try to avoid e to change the connection status when the device is in D ECG mode also immediately prior to that e Do NOT enter data with the insurance card reader when the device is in D ECG mode e Do NOT perform an NIBP measurement at the same time Document name U Allgemein Technische Page 2of9 PE o Ciara and location Bulletins TB_009 TB_009_GB doc f 5 Wy Created 2012 11 19 Released 30 11 2012 f QM Created by Markus Raab Released by Klaus Stemple Sanaa s20 sanaos Safety information Technical Bulletin No 009 cH corpuls 5 Troubleshooting for Conspicuous Devices Re start the monitoring unit Please note that in case of the occurrence of the described malfunction the monitoring unit has to be re started separately that is in modular operation see also chapter 4 2 2 Switching Off of the User Manual To do so hold down the green On Off key until the device shuts down at least 8 seconds After that the monitoring unit can be re started by pressing the same key Switching off In case of a system crash

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