GS
Report
- Report Number
- 8020045-2022-00014
- Event Type
- Malfunction
- Date Received
- June 15, 2022
- Date of Event
- April 17, 2022
- Report Date
- July 13, 2022
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- MKJ
- UDI-DI
- 19005531505302
- PMA / PMN Number
- NONE
- Product Problem
- Yes
- 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. RETAINED SAMPLES OF THE CONCERNED LOT NUMBER (220110-4011) 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. RETAINED SAMPLES OF THE CONCERNED LOT NUMBER (220110-4011) HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE CONCERNED SAMPLE INVOLVED IN THE INCIDENT WAS DISCARDED. ON JUNE 10TH, 2022 WE HAVE RECEIVED TWO ORIGINAL CLOSED POUCHES OF THE CONCERNED LOT NUMBER FROM THE USER FOR FURTHER INVESTIGATION. THE RETURNED SAMPLES HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. AN ELECTRICAL CONTINUITY TEST USING A MULTIMETER FOR BOTH RETURNED DEFIBRILLATION SETS WAS PERFORMED ON ALL METAL COMPONENTS: THE CONNECTOR, THE CABLE, THE RIVET AND THE ELECTRODE ITSELF. NO ELECTRICAL FAILURE OF THE METALLIC COMPONENTS WAS DETECTED. AFTERWARDS THE RETURNED DEFIBRILLATION SETS WERE TESTED FOR THE FUNCTION ON A GS CORPULS 3 DEFIBRILLATOR. THE RETURNED DEFIBRILLATION ELECTRODE SETS HAVE BEEN RECOGNIZED IMMEDIATELY BY THE DEFIBRILLATOR AND SIMULATING A PATIENT INCIDENT ON THE TEST DEVICE FLUKE IMPULSE 7000DP. ALSO A SIMULATED SHOCK ON BOTH TESTED RETURNED DEFIBRILLATION SETS WAS SUCCESSFULLY. THE PACING/STIMULATION MODE WAS ALSO TESTED. NO ABNORMALITIES WERE FOUND HERE EITHER. ON JULY 07TH, 2022 WE HAVE BEEN INFORMED BY COMPANY GS THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]: "THE PROCEDURE RECORDS SHOWS THAT NO THERAPY ELECTRODES WERE DETECTED OVER THE ENTIRE TREATMENT. (CABLE CODE 1: OPEN INPUTS) ALSO, NO VALID IMPEDANCE WAS MEASURED VIA THE THERAPY ELECTRODES. SINCE NO DEFIBRILLATION ELECTRODE LEAD WAS DISPLAYED, THE USER THEN CONNECTED A 4-PIN ECG LEAD FOR MONITORING. SINCE NO DEFECT COULD BE FOUND IN THE DEVICE AND THE ELECTRODES USED ARE NOT AVAILABLE, IT IS NOT POSSIBLE FOR US TO ANALYZE THE CAUSE. A POSSIBLE REASON COULD BE AN INCORRECTLY CONNECTED ELECTRODE OR A DEFECT IN THE ELECTRODE." AS THE CONCERNED PRODUCT INVOLVED IN THE INCIDENT WAS DISCARDED NO CONCLUSION REGARDING THE CAUSE OF THE MALFUNCTION CAN BE DRAWN. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.
ON (B)(6) 2022, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT RESCUE SERVICE DRK KREISVERBAND REMS-MURR IN (B)(6). GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR (CORPULS C3) HAD BEEN USED. THE INITIAL REPORT IS STATING THAT [TRANSLATED FROM (B)(6) LANGUAGE TO ENGLISH LANGUAGE]: AFTER CORRECTLY ATTACHING THE ELECTRODES TO THE PATIENT DURING RESUSCITATION, THE DEFIBRILLATOR DISPLAY SHOWS NO ECG SIGNAL. EVEN AFTER CONNECTING WITHOUT AN EXTENSION CABLE, THE DEFIBRILLATOR DISPLAY STILL SHOWS NO ECG SIGNAL. NO OBVIOUS DAMAGE TO THE ELECTRODES, CABLES INTACT, CONTACT SURFACE ADEQUATELY ADHESIVE AND WITH GOOD SKIN CONTACT. DUE TO THE MISSING ECG SIGNAL, THE RHYTHM ANALYSIS WAS SIGNIFICANTLY DELAYED, THIS WAS CARRIED OUT USING A 4-POLE CABLE AS AN ALTERNATIVE. DEFIBRILLATION WAS NOT NECESSARY. ECG AFTER FUNCTIONAL TEST IN NORMAL FUNCTION. THE CONCERNED DEFIBRILLATION SET HAS BEEN DISCARDED AFTERWARDS. LATER ON WE HAVE RECEIVED A FILLED IN QUESTIONNAIRE. IN THE QUESTIONNAIRE IT WAS DISCLOSED THAT THE MONITORING LASTED FOR ABOUT 2 MINUTES AND THE TREATMENT LASTED FOR 4 MINUTES. THE PATIENT WAS DESCRIBED AS "CACHECTIC" AND THE SKIN TYPE AS PARCHMENT SKIN AND SLIGHTLY HAIRY. THE PATIENT WAS LYING ON HIS BACK. OBJECTIVE OF THE PROCEDURE WAS A "RESUSCITATION". THE DEFIBRILLATION PACKAGING WAS OPENED PRIOR THE USAGE. THE DEFIBRILLATION ELECTRODES WERE PLACED ON THE PATIENT CHEST (STERNUM AND APEX POSITION). THE PATIENT SKIN WAS NOT CLEANED, NOT SHAVEN, NOT DISINFECTED AND NOT DRIED. THE ELECTRODE WAS ADHERING WELL TO THE PATIENT SKIN. FURTHER ON IT WAS SPECIFIED IN THE QUESTIONNAIRE THAT "AS PART OF A RESUSCITATION, THE ELECTRODE SHOULD BE USED FOR RHYTHM ANALYSIS, THE DEFIBRILLATOR DISPLAY SHOWS THAT ELECTRODES ARE PLUGGED IN, BUT SHOWED NO ECG SIGNAL DESPITE SWITCHING OFF / ON".
ON MAY 19TH, 2022, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT RESCUE SERVICE DRK KREISVERBAND REMS-MURR IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR (CORPULS C3) HAD BEEN USED. THE INITIAL REPORT IS STATING THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]: AFTER CORRECTLY ATTACHING THE ELECTRODES TO THE PATIENT DURING RESUSCITATION, THE DEFIBRILLATOR DISPLAY SHOWS NO ECG SIGNAL. EVEN AFTER CONNECTING WITHOUT AN EXTENSION CABLE, THE DEFIBRILLATOR DISPLAY STILL SHOWS NO ECG SIGNAL. NO OBVIOUS DAMAGE TO THE ELECTRODES, CABLES INTACT, CONTACT SURFACE ADEQUATELY ADHESIVE AND WITH GOOD SKIN CONTACT. DUE TO THE MISSING ECG SIGNAL, THE RHYTHM ANALYSIS WAS SIGNIFICANTLY DELAYED, THIS WAS CARRIED OUT USING A 4-POLE CABLE AS AN ALTERNATIVE. DEFIBRILLATION WAS NOT NECESSARY. ECG AFTER FUNCTIONAL TEST IN NORMAL FUNCTION. THE CONCERNED DEFIBRILLATION SET HAS BEEN DISCARDED AFTERWARDS. LATER ON WE HAVE RECEIVED A FILLED IN QUESTIONNAIRE. IN THE QUESTIONNAIRE IT WAS DISCLOSED THAT THE MONITORING LASTED FOR ABOUT 2 MINUTES AND THE TREATMENT LASTED FOR 4 MINUTES. THE PATIENT WAS DESCRIBED AS "CACHECTIC" AND THE SKIN TYPE AS PARCHMENT SKIN AND SLIGHTLY HAIRY. THE PATIENT WAS LYING ON HIS BACK. OBJECTIVE OF THE PROCEDURE WAS A "RESUSCITATION". THE DEFIBRILLATION PACKAGING WAS OPENED PRIOR THE USAGE. THE DEFIBRILLATION ELECTRODES WERE PLACED ON THE PATIENT CHEST (STERNUM AND APEX POSITION). THE PATIENT SKIN WAS NOT CLEANED, NOT SHAVEN, NOT DISINFECTED AND NOT DRIED. THE ELECTRODE WAS ADHERING WELL TO THE PATIENT SKIN. FURTHER ON IT WAS SPECIFIED IN THE QUESTIONNAIRE THAT "AS PART OF A RESUSCITATION, THE ELECTRODE SHOULD BE USED FOR RHYTHM ANALYSIS, THE DEFIBRILLATOR DISPLAY SHOWS THAT ELECTRODES ARE PLUGGED IN, BUT SHOWED NO ECG SIGNAL DESPITE SWITCHING OFF / ON".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2835893 | GS | MULTIFUNCTION DEFIBRILLATION ELECTRODE | MKJ | LEONHARD LANG GMBH | DF53NC | 220110-4011 | 19005531505302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Male | Other |