GS
Report
- Report Number
- 8020045-2022-00031
- Event Type
- Death
- Date Received
- December 15, 2022
- Date of Event
- November 8, 2022
- Report Date
- January 23, 2023
- 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
- 501
Narratives
RETAINED SAMPLES OF THE CONCERNED LOT NUMBER (211108-3996) HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON (B)(6) 2022 THE INVOLVED DEVICE WAS RECEIVED IN AN OPEN POUCH. IT WAS DISINFECTED AND THEN INSPECTED. A VISUAL INSPECTION OF THE DEFIBRILLATION ELECTRODE SET SHOWED NO OBVIOUS DAMAGE. THE CONNECTOR OF THE INVOLVED ELECTRODE SET WAS ALSO VISUALLY INSPECTED. NEITHER DAMAGES NOR DEVIATIONS WERE VISIBLE. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED USING A MULTIMETER TO TEST FOR ELECTRICAL CONTINUITY. THE CONTINUITY TEST WAS PERFORMED TO CHECK THE ELECTRICAL CONTINUITY BETWEEN THE CONNECTOR (PIN APEX AND STERNUM PAD) AND THE ELECTRODE (GEL AREA OF APEX AND STERNUM ELECTRODE). THE CONTINUITY TEST WAS WITHIN LIMITS. AS NO VISUAL AND NO ELECTRICAL CONTINUITY FAILURE COULD BE DETECTED AN ELECTRICAL PERFORMANCE TEST WAS CARRIED ON. THE INVOLVED ELECTRODE SETS WAS ADHERED ONTO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP AND CONNECTED TO THE GS CORPULS DEFIBRILLATOR. THE DEFIBRILLATOR WAS SWITCHED ON AND THE PADS WORKED PROPERLY - IMMEDIATELY AN ECG SIGNAL WAS VISIBLE ON THE DISPLAY. WE HAVE SIMULATED A VENTRICULAR FIBRILLATION AND HAVE SUCCESSFULLY SHOCKED TO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP. ON DECEMBER 5TH WE HAVE RECEIVED AN EXCERPT OF THE DATA THE DEFIBRILATOR HAD RECORDED DURING THE PROCEDURE. THE DATA PROVIDED SHOW NO CLEAR ROOT CAUSE FOR THE CLAIMED FAILURE. WE THEREFORE WILL FURTHER INVESTIGATE THE INVOLVED DEFIBRILLATION ELECTRODESET AT UNIVERSITY HOSPITAL IN (B)(6). THEREBY AN X-RAY INVESTIGATION WILL BE CARRIED OUT ON ALL METAL PARTS OF THE DEFIBRILLATION ELECTRODE SET. ONCE THIS INFORMATION BECOMES AVAILABLE WE WILL PROVIDE A FOLLOW-UP REPORT. SO FAR, NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. THIS PRODUCT IS NOT MARKETED IN THE USA. NO 510 (K) AND NO PMA EXIST FOR IT. 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 (211108-3996) HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON (B)(6), 2022 THE INVOLVED DEVICE WAS RECEIVED IN AN OPEN POUCH. IT WAS DISINFECTED AND THEN INSPECTED. A VISUAL INSPECTION OF THE DEFIBRILLATION ELECTRODE SET SHOWED NO OBVIOUS DAMAGE. THE CONNECTOR OF THE INVOLVED ELECTRODE SET WAS ALSO VISUALLY INSPECTED. NEITHER DAMAGES NOR DEVIATIONS WERE VISIBLE. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED USING A MULTIMETER TO TEST FOR ELECTRICAL CONTINUITY. THE CONTINUITY TEST WAS PERFORMED TO CHECK THE ELECTRICAL CONTINUITY BETWEEN THE CONNECTOR (PIN APEX AND STERNUM PAD) AND THE ELECTRODE (GEL AREA OF APEX AND STERNUM ELECTRODE). THE CONTINUITY TEST WAS WITHIN LIMITS. AS NO VISUAL AND NO ELECTRICAL CONTINUITY FAILURE COULD BE DETECTED AN ELECTRICAL PERFORMANCE TEST WAS CARRIED ON. THE INVOLVED ELECTRODE SETS WAS ADHERED ONTO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP AND CONNECTED TO THE GS CORPULS DEFIBRILLATOR. THE DEFIBRILLATOR WAS SWITCHED ON AND THE PADS WORKED PROPERLY - IMMEDIATELY AN ECG SIGNAL WAS VISIBLE ON THE DISPLAY. WE HAVE SIMULATED A VENTRICULAR FIBRILLATION AND HAVE SUCCESSFULLY SHOCKED TO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP. ON (B)(6) WE HAVE RECEIVED AN EXCERPT OF THE DATA THE DEFIBRILATOR HAD RECORDED DURING THE PROCEDURE. THE DATA PROVIDED SHOW NO CLEAR ROOT CAUSE FOR THE CLAIMED FAILURE. WE THEREFORE HAVE FURTHER INVESTIGATED THE INVOLVED DEFIBRILLATION ELECTRODE SET AT THE UNIVERSITY HOSPITAL IN INNSBRUCK. THEREBY AN X-RAY INVESTIGATION WAS CARRIED OUT ON ALL METAL PARTS OF THE DEFIBRILLATION ELECTRODE SET. AN ANOMALY CONCERNING AN EEPROM WAS DISCOVERED IN THE INVOLVED CUSTOMER SAMPLE. THE EEPROM IS CODED WITH THE SHELF LIFE INFORMATION. IN AN INTERNAL TEST THE EEPROM COULD BE READ. IT IS THEREFORE UNCLEAR WHETHER THE ANOMALY CONSTITUTES A DAMAGE. IN ANY CASE, THE EEPROM HAS NO FUNCTION WHEN USED WITH A CORPULS C3 DEFIBRILLATOR. WE CAN THEREFORE RULE OUT IT PLAYED ANY ROLE IN THE INCIDENT. NO CABLE BREAK OR SHORT CIRCUIT IN THE PLUG WAS DETECTED, WHICH WOULD HAVE BEEN A POTENTIAL ROOT CAUSE FOR THE INCIDENT. ALL COMPONENTS THAT CAN LEAD TO THE REPORTED DEFECT OR ERROR MESSAGES DO NOT SHOW ANY ABNORMALITIES. THE FUNCTION TEST OF THE INVOLVED CUSTOMER SAMPLE SHOWED NO DEVIATION. BASED ON THE INVESTIGATION RESULTS OF THE INVOLVED CUSTOMER SAMPLE AND THE PROVIDED INFORMATION ON THE PROCEDURE NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE INCIDENT. WE THEREFORE CLOSE THE INVESTIGATION. THIS PRODUCT IS NOT MARKETED IN THE USA. NO 510 (K) AND NO PMA EXIST FOR IT. HOWEVER, DEVICES MADE USING A SIMILAR DESIGN ARE SOLD IN THE US. WE ARE THEREFORE REPORTING THIS INCIDENT.
ON (B)(6) 2022 , WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT ARBEITER-SAMARITER-BUND (ASB) HANNOVER IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 04324.3 CORPATCH EASY SCHALE (MODEL DF23T) AND A GS CORPULS DEFIBRILLATOR C3 HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "ON (B)(6) 2022 AT 5:56 P.M., THE FOLLOWING INCIDENT OCCURRED DURING A HOME RESCUE SERVICE (RESUSCITATION). A PATIENT AGED 62 COULD NOT BE DEFIBRILLATED IMMEDIATELY. THE DEFIBRILLATION ELECTRODES WERE PROFESSIONALLY GLUED ON THE PATIENT BUT DID NOT DELIVER ANY SIGNAL. AN ERROR MESSAGE WAS DISPLAYED IN THE ECG [OF THE DEFIBRILLATOR GS CORPULS C3]. THE SAME ERROR ALSO OCCURRED ON THE ECG FROM THE EMERGENCY RESCUE SERVICE [ON A SECOND DEFIBRILLATOR GS CORPULS C3]" THEREBY THE DEFIBRILLATOR FROM THE EMERGENCY RESCUE SERVICE WAS ALSO CONNECTED TO THE ELECTRODES ALREADY APPLIED AND THE ERROR WAS ALSO DISPLAYED HERE. "THE BASIC REANIMATION HAVE BEEN CONTINUED. AFTER CHANGING THE DEFIBRILLATION ELECTRODES, THE PATIENT COULD BE DEFIBRILLATED. 4-5 MINUTES DELAY IN DEFIBRILLATION. PATIENT DIED ON SITE. DEFIBRILLATION ELECTRODES AND ECG WERE SECURED" WE HAVE REQUESTED FURTHER INFORMATION ON THE INCIDENT AND THE INVOLVED SAMPLES.
ON (B)(6), 2022, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT ARBEITER-SAMARITER-BUND (ASB) HANNOVER IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 04324.3 CORPATCH EASY SCHALE (MODEL DF23T) AND A GS CORPULS DEFIBRILLATOR C3 HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "ON (B)(6), 2022 AT 5:56 P.M., THE FOLLOWING INCIDENT OCCURRED DURING A HOME RESCUE SERVICE (RESUSCITATION). A PATIENT AGED 62 COULD NOT BE DEFIBRILLATED IMMEDIATELY. THE DEFIBRILLATION ELECTRODES WERE PROFESSIONALLY GLUED ON THE PATIENT BUT DID NOT DELIVER ANY SIGNAL. AN ERROR MESSAGE WAS DISPLAYED IN THE ECG [OF THE DEFIBRILLATOR GS CORPULS C3]. THE SAME ERROR ALSO OCCURRED ON THE ECG FROM THE EMERGENCY RESCUE SERVICE [ON A SECOND DEFIBRILLATOR GS CORPULS C3]" THEREBY THE DEFIBRILLATOR FROM THE EMERGENCY RESCUE SERVICE WAS ALSO CONNECTED TO THE ELECTRODES ALREADY APPLIED AND THE ERROR WAS ALSO DISPLAYED HERE. "THE BASIC REANIMATION HAVE BEEN CONTINUED. AFTER CHANGING THE DEFIBRILLATION ELECTRODES, THE PATIENT COULD BE DEFIBRILLATED. 4-5 MINUTES DELAY IN DEFIBRILLATION. PATIENT DIED ON SITE. DEFIBRILLATION ELECTRODES AND ECG WERE SECURED" WE HAVE REQUESTED FURTHER INFORMATION ON THE INCIDENT AND THE INVOLVED SAMPLES. LATER ON WE HAVE BEEN INFORMED THAT NO THERAPY CABLE, I.E. AN EXTENSION CABLE BETWEEN THE DEFIBRILLATION CABLE AND THE DEFIBRILLATOR, WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1626530 | GS | MULTIFUNCTION DEFIBRILLATION ELECTRODE | MKJ | LEONHARD LANG GMBH | DF23T | 211108-3996 | 19005531505302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Unknown | Death |