GS
Report
- Report Number
- 8020045-2022-00006
- Event Type
- Malfunction
- Date Received
- March 30, 2022
- Date of Event
- December 28, 2021
- Report Date
- May 3, 2022
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- MKJ
- UDI-DI
- 19005531505302
- PMA / PMN Number
- NONE
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
NO 510 (K) AND NO PMA EXIST FOR THIS PRODUCT. IT IS NOT MARKETED IN THE USA. HOWEVER, DEVICES MADE USING A SIMILAR DESIGN ARE SOLD IN THE US. WE ARE THEREFORE REPORTING THIS INCIDENT. THE CONCERNED DEFIBRILLATION ELECTRODE SET WAS DISPOSED OF IMMEDIATELY AFTER USE. THE CONCERNED LOT NUMBER IS NOT KNOWN AND COULD NOT BE CLEARLY DEFINED AFTERWARDS. WE HAVE BEEN INFORMED THAT ACCORDING TO THE CUSTOMER'S ORDERS, THE FOLLOWING LOT NUMBERS 210825-4017 AND 211025-4016 MAY BE AFFECTED. RETAINED SAMPLES OF THE TWO CONCERNED LOT NUMBERS HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. CURRENTLY NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE FURTHER RESULTS.
NO 510 (K) AND NO PMA EXIST FOR THIS PRODUCT. IT IS NOT MARKETED IN THE USA. HOWEVER, DEVICES MADE USING A SIMILAR DESIGN ARE SOLD IN THE US. WE ARE THEREFORE REPORTING THIS INCIDENT. THE CONCERNED DEFIBRILLATION ELECTRODE SET WAS DISPOSED OFF IMMEDIATELY AFTER USE. THE CONCERNED LOT NUMBER IS NOT KNOWN AND COULD NOT BE CLEARLY DEFINED AFTERWARDS. WE HAVE BEEN INFORMED THAT ACCORDING TO THE CUSTOMER'S ORDERS, THE FOLLOWING LOT NUMBERS: 210825-4017 AND 211025-4016 MAY BE AFFECTED. RETAINED SAMPLES OF THE TWO CONCERNED LOT NUMBERS HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. WE ALSO HAVE DONE AN ELECTRICAL CONTINUITY TEST USING A MULTIMETER FOR BOTH POSSIBLE AFFECTED LOT NUMBERS: 210825-4017 AND 211025-4016. IN THE COURSE OF INVESTIGATION OF THIS COMPLAINT AND OF COMPLAINT: (B)(6) (MFR REPORT#: 8020045-2022-00007), IT WAS FOUND THAT SOME CONNECTORS SHOW A DEFECT CONCERNING THE CODING RESISTOR. THE ROOT CAUSE WAS IDENTIFIED TO BE THE METHOD (CRIMPING) THE RESISTOR WAS CONNECTED WITH TO THE RESPECTIVE CONTACT PINS. THE CORRECTIVE ACTION WILL BE THE INTRODUCTION OF A SOLDERING PROCESS TO CONNECT THE RESISTOR TO THE CONTACT PINS IN THE CONNECTOR. AS NO COMPARABLE CONNECTOR WITH A CRIMPED RESISTOR OR SIMILAR CRIMPED COMPONENT IS MARKETED IN THE US AND NO PMA OR 510K EXIST FOR THE COMPLAINED PRODUCT, WE CONSIDER THE INCIDENT NO LONGER REPORTABLE.
ON MARCH 30TH, 2021, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN RESCUE SERVICE PRESUMABLY IN (B)(6). GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53C) AND A GS CORPULS DEFIBRILLATOR (MODEL UNKNOWN) HAD BEEN USED. THE INITIAL REPORT IS STATING THAT [TRANSLATED FROM (B)(6) LANGUAGE TO ENGLISH LANGUAGE]: THE CORPATCH THERAPY ELECTRODES WERE APPLIED TO THE PATIENT REQUIRING RESUSCITATION. THE PATIENT WAS NOT COLD SWEATING AND HAD LITTLE HAIR. THE DEVICE [GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53C)] REPEATEDLY REPORTED DESPITE RECONNECTING THE PLUG: STICK ON THERAPY ELECTRODES. ANALYSIS AND SHOCK DELIVERY WAS NOT POSSIBLE. ANOTHER DEVICE WAS QUICKLY TAKEN. THE CONCERNED DEFIBRILLATION ELECTRODE SET WAS DISPOSED OF IMMEDIATELY AFTER USE. THE CONCERNED LOT NUMBER IS NOT KNOWN AND COULD NOT BE CLEARLY DEFINED AFTERWARDS. REQUESTING FURTHER INFORMATION WE HAVE BEEN INFORMED THAT THERE WAS NO PATIENT DETERIORATION DUE TO THE DELAY IN THERAPY. IT WAS ALSO STATED THAT THE DELAY IN THERAPY HAVE NO IMPACT ON THE PATIENT.
ON MARCH 03TH, 2021, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT A UNKNOWN RESCUE SERVICE BRAUNSCHWEIG IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER: 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL: DF53C) AND A GS CORPULS DEFIBRILLATOR (MODEL: UNKNOWN) HAD BEEN USED. THE INITIAL REPORT IS STATING THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]: THE CORPATCH THERAPY ELECTRODES WERE APPLIED TO THE PATIENT REQUIRING RESUSCITATION. THE PATIENT WAS NOT COLD SWEATING AND HAD LITTLE HAIR. THE DEVICE [GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER: 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL: DF53C)] REPEATEDLY REPORTED DESPITE RECONNECTING THE PLUG: STICK ON THERAPY ELECTRODES. ANALYSIS AND SHOCK DELIVERY WAS NOT POSSIBLE. ANOTHER DEVICE WAS QUICKLY TAKEN. THE CONCERNED DEFIBRILLATION ELECTRODE SET WAS DISPOSED OF IMMEDIATELY AFTER USE. THE CONCERNED LOT NUMBER IS NOT KNOWN AND COULD NOT BE CLEARLY DEFINED AFTERWARDS. REQUESTING FURTHER INFORMATION WE HAVE BEEN INFORMED THAT THERE WAS NO PATIENT DETERIORATION DUE TO THE DELAY IN THERAPY. IT WAS ALSO STATED THAT THE DELAY IN THERAPY HAVE NO IMPACT ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 783674 | GS | MULTIFUNCTION DEFIBRILLATION ELECTRODE | MKJ | LEONHARD LANG GMBH | DF53NC | 210825-4017 | 19005531505302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |