GS CORPATCH
Report
- Report Number
- 8020045-2025-00022
- Event Type
- Malfunction
- Date Received
- October 8, 2025
- Date of Event
- July 15, 2025
- Report Date
- December 9, 2025
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- MKJ
- UDI-DI
- 19005531002498
- PMA / PMN Number
- NONE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 501
Narratives
THIS PRODUCT IS NOT MARKETED IN THE USA. NO 510 (K) AND NO PMA EXISTS 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 240711-4897 HAVE BEEN INSPECTED VISUALLY, ELECTRICALLY AND TESTED FOR THE ADHESION. ALL TESTED ELECTRODES WERE WITHIN LIMITS; NO FAILURE COULD BE DETECTED. ON (B)(6) 2025 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 AND THE CABLE OF THE INVOLVED ELECTRODE SET WAS ALSO VISUALLY INSPECTED. NEITHER DAMAGES NOR DEVIATIONS WERE VISIBLE. THE FOAM CABLE INSULATION AT THE DEFIBRILLATION ELECTRODES PROTECT THE CABLE CONDUCTORS WITH THE RING TERMINALS DIDN'T SHOW ANY BURNT MARK OR DISCOLORATION. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED USING A MULTIMETER TO TEST FOR ELECTRICAL CONTINUITY. A 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 SAMPLE PAIR WAS WITHIN LIMITS. WE HAVE FURTHER INVESTIGATED THE INVOLVED DEFIBRILLATION ELECTRODE SET AT UNIVERSITY HOSPITAL IN INNSBRUCK. THERE AN X-RAY INVESTIGATION WAS CARRIED OUT ON ALL METAL PARTS OF THE DEFIBRILLATION ELECTRODE SET. ON NOVEMBER 19TH, 2023 WE HAVE RECEIVED THE X-RAY INVESTIGATION RESULTS / PICTURES AND NO FAILURE OR ROOT CAUSE CAN BE DETECTED. WE THEREFORE HAVE FURTHER INVESTIGATED THE INVOLVED DEFIBRILLATION ELECTRODE SET WITH A COMPUTER TOMOGRAPHY. THE CT RESULTS OF THE ELECTRODE SET INVOLVED SHOWED NO ANOMALIES OR DEVIATIONS. AFTERWARDS 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 C3 DEFIBRILLATOR. THE DEFIBRILLATOR WAS SWITCHED ON AND THE PADS WERE IMMEDIATELY RECOGNIZED BY THE DEFIBRILLATOR AND AN ECG SIGNAL WAS VISIBLE ON THE DEFIBRILLATOR DISPLAY. WE HAVE SIMULATED A VENTRICULAR FIBRILLATION AND HAVE SUCCESSFULLY SHOCKED TO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP. IN TOTAL 3 TIMES HAVE BEEN SHOCKED TO THE DEFIBRILLATION ELECTRODES IN AUTOMATIC AND MANUAL MODE. TRYING TO REPRODUCE THE DESCRIBED FAULT, WE DID NOT FULLY ADHERED THE ELECTRODES TO THE MEASURING SURFACES ON THE TEST DEVICE IN ORDER TO NOT FULLY COVER THE CONDUCTIVE METALLIC SURFACES. WE ALSO HAVE EXPOSED THE CABLE CONDUCTORS WITH THE RING TERMINALS OF THE DEFIBRILLATION ELECTRODES. EVEN WITH THIS SETTING THERE WAS NO SPARK OR ARCING VISIBLE WHEN THE DEFIBRILLATION ELECTRODES WERE SHOCKED. IT WAS NOT POSSIBLE TO OBSERVE THE CLAIMED FAILURE WHEN INVESTIGATING THE CONCERNED CUSTOMER SAMPLE. WE WERE NOT ABLE DETECT ANY FAILURE. NO FURTHER CONCLUSION CAN BE DRAWN. HOWEVER, THE IFU STATES THAT "ALWAYS KEEP A SECOND PACK OF ELECTRODES WITH THE DEFIBRILLATOR". WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT CLOSED.
THIS PRODUCT IS NOT MARKETED IN THE USA. NO 510 (K) AND NO PMA EXISTS 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 240711-4897 HAVE BEEN INSPECTED VISUALLY, ELECTRICALLY AND TESTED FOR THE ADHESION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. WE HAVE REQUESTED THE INVOLVED SAMPLE AND HAVE BEEN INFORMED ON (B)(6) 2025 THAT "THE ELECTRODE WILL BE SENT TO YOU DIRECTLY BY OUR SERVICE PARTNER". WE ARE CURRENTLY AWAITING THE INVOLVED SAMPLES FOR FURTHER INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT ONCE FURTHER INFORMATION OR A ROOT CAUSE HAVE BEEN DETECTED.
ON (B)(6) 2024, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER SITE IN AUSTRALIA. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.5 CORPATCH EASY PRE-CONNECT (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "DURING A CHARGE (200J) AND SUBSEQUENT SHOCK DELIVERY A VISIBLE SPARK WAS OBSERVED FROM THE ANTERIOR PAD, A POP NOISE OCCURRED AND AN ELECTRICAL BURNING SMELL IMMEDIATELY POST THE SHOCK OCCURRED" WE HAVE REQUESTED FURTHER DETAILS FOR CUSTOMER SAMPLES AND A FILLED IN QUESTIONNAIRE AND HAVE RECEIVED A FILLED IN QUESTIONNAIRE ON OCTOBER 2ND, 2025. A PATIENT SUFFERED A CARDIAC ARREST. THE DURATION OF MONITORING LASTED FOR "APPROX 20MINUTES". THE PATIENT WAS DESCRIBED AS OF SLIM ELDERLY MALE BODY TYPE. THE GENERAL STATE AND THE SKIN TYPE AS NORMAL. THE PATIENT WAS LYING IN THE SUPINE POSITION ON THE CARPET FLOOR. IT WAS ALSO REPORTED THAT NO SKIN PREPARATION WAS PERFORMED. NO SHAVING, NO CLEANING, NO DISINFECTION AND NO DRYING HAD BEEN PERFORMED PRIOR APPLYING THE DEFIBRILLATION ELECTRODES. THE DEFIBRILLATION PACKAGING WAS OPENED RIGHT BEFORE PADS WERE PLACED ON THE PATIENT". THE ELECTRODES HAD BEEN PLACED ANTERIOR AND POSTERIOR ON THE PATIENT. IT WAS REPORTED THAT NO IMPAIRMENT OF THE SKIN, NO LIQUIDS WERE UNDERNEATH THE SKIN AND THE ELECTRODES, NO WRINKLES OR BLISTERS FORM ON THE SKIN AND NO HAIR WAS VISIBLE PRESENT UNDERNEATH THE ELECTRODE AT THE SITE OF APPLICATION. IT WAS ALSO REPORTED THAT THE ELECTRODES ADHERED PROPERLY TO THE PATIENT SKIN. ONE DEFIBRILLATION SHOCK WITH 200J WAS DELIVERED TO THE PATIENT. FURTHER ON IT WAS REPORTED THAT "DURING ADMINISTERING THE SHOCK WHERE THE CORDS GO INTO THE PAD" A FLASH WAS NOTICEABLE AT THE "ANTERIOR PAD". "NO VISIBLE INJURY PRESENT" SO "PADS WERE IMMEDIATELY REMOVED + REPLACED WITH NEW PADS". WE HAVE REQUESTED FURTHER INFORMATION ON THE PATIENT OUTCOME AND THE CONCERNED AND INVOLVED CUSTOMER SAMPLE. NO FURTHER DETAILS HAVE BEEN DISCLOSED.
ON (B)(6) 2024, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER SITE IN AUSTRALIA. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.5 CORPATCH EASY PRE-CONNECT (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "DURING A CHARGE (200J) AND SUBSEQUENT SHOCK DELIVERY A VISIBLE SPARK WAS OBSERVED FROM THE ANTERIOR PAD, A POP NOISE OCCURRED AND AN ELECTRICAL BURNING SMELL IMMEDIATELY POST THE SHOCK OCCURRED." WE HAVE REQUESTED FURTHER DETAILS FOR CUSTOMER SAMPLES AND A FILLED IN QUESTIONNAIRE AND HAVE RECEIVED A FILLED IN QUESTIONNAIRE ON OCTOBER 2ND, 2025. A PATIENT SUFFERED A CARDIAC ARREST. THE DURATION OF MONITORING LASTED FOR "APPROX 20MINUTES". THE PATIENT WAS DESCRIBED AS OF SLIM ELDERLY MALE BODY TYPE. THE GENERAL STATE AND THE SKIN TYPE AS NORMAL. THE PATIENT WAS LYING IN THE SUPINE POSITION ON THE CARPET FLOOR. IT WAS ALSO REPORTED THAT NO SKIN PREPARATION WAS PERFORMED. NO SHAVING, NO CLEANING, NO DISINFECTION AND NO DRYING HAD BEEN PERFORMED PRIOR APPLYING THE DEFIBRILLATION ELECTRODES. THE DEFIBRILLATION PACKAGING WAS OPENED RIGHT BEFORE PADS WERE PLACED ON THE PATIENT". THE ELECTRODES HAD BEEN PLACED ANTERIOR AND POSTERIOR ON THE PATIENT. IT WAS REPORTED THAT NO IMPAIRMENT OF THE SKIN, NO LIQUIDS WERE UNDERNEATH THE SKIN AND THE ELECTRODES, NO WRINKLES OR BLISTERS FORM ON THE SKIN AND NO HAIR WAS VISIBLE PRESENT UNDERNEATH THE ELECTRODE AT THE SITE OF APPLICATION. IT WAS ALSO REPORTED THAT THE ELECTRODES ADHERED PROPERLY TO THE PATIENT SKIN. ONE DEFIBRILLATION SHOCK WITH 200J WAS DELIVERED TO THE PATIENT. FURTHER ON IT WAS REPORTED THAT "DURING ADMINISTERING THE SHOCK WHERE THE CORDS GO INTO THE PAD" A FLASH WAS NOTICEABLE AT THE "ANTERIOR PAD". "NO VISIBLE INJURY PRESENT" SO "PADS WERE IMMEDIATELY REMOVED + REPLACED WITH NEW PADS". WE HAVE REQUESTED FURTHER INFORMATION ON THE PATIENT OUTCOME AND THE CONCERNED AND INVOLVED CUSTOMER SAMPLE. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336451 | GS CORPATCH | MULTIFUNCTION DEFIBRILLATION ELECTRODE | MKJ | LEONHARD LANG GMBH | DF53NC | 240711-4897 | 19005531002498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Male | Other |