corpuls - Swissmedic
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1. 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 lf you have supplied the products to third parties please forward a copy of this safety information to them and also inform the below chapter 9 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 2014 08 08 Maintenance for each device will be promptly arranged A different software version 2 2 4 or higher will be installed to your device so you will soon have a fully operational device The zero re adjustment will the be performed at larger intervals see Fig 2 Example with the planned SW 2 2 4 Imi mf 1 F i F Fig 2 corpuls with SW 2 2 4 Drifting ECG the zero re adjustment in the red frame For the duration of the maintenance a replacement device will be supplied Dokumentenname TB_013_GB pdf Seite 3 von 9 Erstelldatum 28 07 2014 Freigabedatum 29 07 2014 Ersteller Name Markus Raab Freigabe Name Klaus Stemple GS Elektromed Ger te Managing Board Bankverbindung Visit us at G Stemple GmbH G Stemple K Stemple Dr C Klimmer Klimmer IBAN DE20 7009 3200 0008 6801 24 m Hauswiesenstr 26 Registergericht Augsburg HRB 3373 BIC GEN2. 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 understanding and apologise for any inconvenience you may have in connection with this corrective action Questions concerning this matter will be answered by your local authorized corpuls sales and service partner see also Annex C or www corpuls com Kind regards GS Elektromedizinische Ger te G Stemple GmbH Klaus Stemple Dipl Ing Electrical and Computer Engineering CEO CTO R amp D Production Product Safety Safety representative for medical products pursuant to 30 MPG Dokumentenname TB_013_GB pdf Seite 5 von 9 Erstelldatum 28 07 2014 Freigabedatum 29 07 2014 Ersteller Name Markus Raab Freigabe Name Klaus Stemple GS Elektromed Ger te Managing Board Bankverbindung G Stemple GmbH G Stemple K Stemple Dr C Klimmer Klimmer IBAN DE20 7009 3200 0008 6801 24 Hauswiesenstr 26 Registergericht Augsburg HRB 3373 BIC GENODEF1STH D 86916 Kaufering USt Id DE 128 668 535 Safety information Technical Bulletin No 013 Annex A 1 Monitoring Unit 2 Patient box 3 Defibrillator Illustration of the device combination corpuls with Defibrillator SLIM 1 Monitoring Unit 2 Patient box 3 Defibrillator SLIM Illustration of the device combination corpuls e actual Rating plates with position of the serial numbers me GS Elektromedizinische Ger te GmbH
3. 3200 0008 6801 24 4 Hauswiesenstr 26 Registergericht Augsburg HRB 3373 BIC GENODEF1STH D 86916 Kaufering USt Id DE 128 668 535 m Safety information Technical Bulletin No 009 cH ome Annex D Serial numbers of corpuls that are affected in your company according to our records by the problem with software version 2 2 2 Serial numbers of devices with installed software version 2 2 2 Monitoring Unit Patient box Defibrillator Dokumentenname TB_013_GB pdf Seite 9 von 9 Erstelldatum 28 07 2014 Freigabedatum 29 07 2014 Ersteller Name Markus Raab Freigabe Name Klaus Stemple GS Elektromed Ger te Managing Board Bankverbindung Visit us at G Stemple GmbH G Stemple K Stemple Dr C Klimmer Klimmer IBAN DE20 7009 3200 0008 6801 24 4 Hauswiesenstr 26 Registergericht Augsburg HRB 3373 BIC GENODEF1STH D 86916 Kaufering USt Id DE 128 668 535 m
4. ODEF1STH D 86916 Kaufering USt Id DE 128 668 535 m Safety information Technical Bulletin No 013 c gt corpuls 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 have been informed 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 2014 08 22 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 2014 09 26 at the latest Dokumentenname TB_013_GB pdf Seite 4 von 9 Erstelldatum 28 07 2014 Freigabedatum 29 07 2014 Ersteller Name Markus Raab Freigabe Name Klaus Stemple GS Elektromed Ger te Managing Board Bankverbindung Visit us at G Stemple GmbH G Stemple K Stemple Dr C Klimmer Klimmer IBAN DE20 7009 3200 0008 6801 24 Hauswiesenstr 26 Registergericht Augsburg HRB 3373 BIC GENODEF1STH D 86916 Kaufering USt Id DE 128 668 535 m Safety information Technical Bulletin No 013 9 Contact person of the manufacturer for questions Carsten Fuchs Vice President Customer Support Head of Customer Support
5. Safety information Technical Bulletin No 013 c gt 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 013 Affected users 2014 07 29 9 Affected products Serial numbers Lot identification Software Firmware corpuls No relation Software Version 2 2 2 Dear sir or madam with this letter we would like to inform you about the recall of software versions 2 2 2 that have been installed to a limited number of corpuls devices During the recording of an D ECG for diagnostic purposes a non intended technical distortion of the R spike or the ST segment may occur 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 2014 08 22 So far we do not have information that other software versions for corpuls devices are also affected by this problem The responsible supervisory authorities of the involved countries and your local authorized corpuls sales and service partner have been informed about this FSCA Field Safety Corrective Action Dokument
6. enname TB_013_GB pdf Seite 1 von 9 Erstelldatum 28 07 2014 Freigabedatum 29 07 2014 Ersteller Name Markus Raab Freigabe Name Klaus Stemple GS Elektromed Ger te Managing Board Bankverbindung Visit us at G Stemple GmbH G Stemple K Stemple Dr C Klimmer Klimmer IBAN DE20 7009 3200 0008 6801 24 4 Hauswiesenstr 26 Registergericht Augsburg HRB 3373 BIC GENODEF1STH D 86916 Kaufering USt Id DE 128 668 535 m Safety information Technical Bulletin No 013 c gt corpuls 1 Error description If a drifting ECG signal is present at input the ECG signal will be kept in the display area by means of an correction mechanism This correction mechanism is performed in the affected software version SW 2 2 2 at too close intervals If this technically necessary zero re adjustment occurs at the same time as the R spike or the ST segment it may not be interpreted as distortion or correction see Fig 1 with a current example from SW 2 2 2 Therefore it is possible that the user may misinterpret the curve Fig 1 corpuls with SW 2 2 2 Drifting ECG the zero re adjustment is marked in yellow 2 Prerequisite for the Occurrence of the Error One the software versions identified as problematic 2 2 2 is installed on your device If the heart rate and the interval for zero re adjustment dependent on the drifting speed are almost identical it is particularly difficult to identify the correction as such 3 Potential Ri
7. ey 86916 Kaufering Made in Germany Display Unit corpul 612 V 30 W rer 04100 um amp 0123 Dokumentenname Erstelldatum Ersteller Name GS Elektromed Gerate G Stemple GmbH Hauswiesenstr 26 D 86916 Kaufering Ey GS Elektromedizinische Ger te GmbH 9 GS Elektromedizinische Ger te GmbH gS 86916 Kaufering Made in Germany 86916 Kaufering Made in Germany Patient Box corpuls 12V 30W Defib Unit corpuls 12 V 74W rer 04200 FEF 04300 im SER mm ER u Ge 2 CE O Ky GS Elektromedizinische Gerate GmbH 86916 Kaufering Made in Germany Defib corpuls SLIM O12 V 74 W u X A 0 CE 2 TB_013_GB pdf Seite 6 von 9 28 07 2014 Freigabedatum 29 07 2014 Markus Raab Freigabe Name Klaus Stemple Managing Board Bankverbindung Visit us at G Stemple K Stemple Dr C Klimmer Klimmer IBAN DE20 7009 3200 0008 6801 24 m Registergericht Augsburg HRB 3373 BIC GENODEF1STH USt Id DE 128 668 535 m Safety information Technical Bulletin No 013 c gt corpuls Annex B Confirmation form Please mark with a cross ALL fields that apply to your company Q We have read and understood the safety information of GS Elektromedizinische Ger te G Stemple GmbH of 2014 07 29 Q We have informed our users in an appropriate way about the contents of this safety information and the amendment to the user manual Ci We are attaching Annex D if necessary with corrected serial no of
8. sk The ECG may be misinterpreted and this may lead to a wrong therapy or therapy preparations e g catheter lab 4 Safety information Please do notify your users as soon as possible about e possible malfunctions that can occur and relevant corrective measures If this effect is known to the user the regular correction intervals can be competently identified and taken into account when interpreting the ECG Dokumentenname TB_013_GB pdf Seite 2 von 9 Erstelldatum 28 07 2014 Freigabedatum 29 07 2014 Ersteller Name Markus Raab Freigabe Name Klaus Stemple GS Elektromed Ger te Managing Board Bankverbindung Visit us at G Stemple GmbH G Stemple K Stemple Dr C Klimmer Klimmer IBAN DE20 7009 3200 0008 6801 24 Hauswiesenstr 26 Registergericht Augsburg HRB 3373 BIC GENODEF1STH D 86916 Kaufering USt Id DE 128 668 535 m Safety information Technical Bulletin No 013 c gt corpuls 5 Troubleshooting for Conspicuous Devices It is possible to avoid or suppress this zero re adjustment effect by positioning the patient and the ECG cable differently and by avoiding patient movement during a diagnostic ECG recording The probability that this error occurs is lessened as well when quick response electrode are used and the recommendations of the electrode manufacturer on how to pre treat the patient s skin are complied with A permanent correction of the error is only possible by installing a different software version
9. 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 2014 08 22 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 Dokumentenname TB_013_GB pdf Seite 7 von 9 Erstelldatum 28 07 2014 Freigabedatum 29 07 2014 Ersteller Name Markus Raab Freigabe Name Klaus Stemple GS Elektromed Ger te Managing Board Bankverbindung Visit us at G Stemple GmbH G Stemple K Stemple Dr C Klimmer Klimmer IBAN DE20 7009 3200 0008 6801 24 m Hauswiesenstr 26 Registergericht Augsburg HRB 3373 BIC GENODEF1STH D 86916 Kaufering USt Id DE 128 668 535 m Safety information Technical Bulletin No 013 Annex C Your local authorized corpuls sales and service partner Please consult our homepage for international authorized sales and service addresses www corpuls com Dokumentenname TB_013_GB pdf Seite 8 von 9 Erstelldatum 28 07 2014 Freigabedatum 29 07 2014 Ersteller Name Markus Raab Freigabe Name Klaus Stemple GS Elektromed Ger te Managing Board Bankverbindung Visit us at G Stemple GmbH G Stemple K Stemple Dr C Klimmer Klimmer IBAN DE20 7009
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