GS
Report
- Report Number
- 8020045-2023-00019
- Event Type
- Malfunction
- Date Received
- June 14, 2023
- Report Date
- July 10, 2024
- 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 221019-4015 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON MAY 23RD, 2023 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. ONE 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 WAS WITHIN LIMITS. ANOTHER CONTINUITY TEST WAS PERFORMED TO CHECK CONTINUITY BETWEEN THE TWO PINS OF A RESISTOR IN THE CONNECTOR. THIS TEST REVEALED THAT THE CODING RESISTOR'S VALUE CANNOT BE MEASURED. 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 HAVE NOT BEEN RECOGNIZED BY THE DEFIBRILLATOR. THE DEFIBRILLATOR SHOWED ON THE DISPLAY THE MESSAGE: "CONNECT THERAPY ELECTRODES". WE WILL FURTHER INVESTIGATE THE INVOLVED DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL IN INNSBRUCK. THERE AN X-RAY INVESTIGATION WILL BE CARRIED OUT ON ALL METAL PARTS OF THE DEFIBRILLATION ELECTRODE SET TO DETERMINE IF THERE IS ANY BREAKAGE. ON (B)(6) 2023 WE HAVE RECEIVED THE X-RAY INVESTIGATION RESULTS / PICTURES AND NO CLEAR ROOT CAUSE CAN BE DETECTED. WE WILL THEREFORE FURTHER INVESTIGATE THE INVOLVED DEFIBRILLATION ELECTRODE SET WITH A COMPUTED TOMOGRAPHY DETECTING THE ROOT CAUSE. WE RECEIVED THE CT RESULTS OF THE ELECTRODE SET INVOLVED FROM COMPUTED TOMOGRAPHY ON (B)(6) 2023. THE IMAGES REVEALED ANOMALIES: 1) IT CAN BE SEEN THAT THE USED SOLDERING BUSH DOES NOT COMPLY TO THE SPECIFICATIONS. 2) IT CAN BE SEEN THAT THE SOLDERING BUSH WAS FILLED WITH TOO LITTLE SOLDER PASTE. LEONHARD LANG TECHNICIANS HAVE VISITED THE CABLE SUPPLIER AND DISCUSSED THE DETECTED FAILURES. AS AN IMMEDIATE MEASURE, THE PRODUCTION AT THE SUPPLIER WAS STOPPED. SO FAR, ONE SET OF ELECTRODES HAS BEEN REPORTED AS FAULTY. TO DETERMINE THE PROBABILITY OF OCCURRENCE, (B)(4) CABLE PLUGS HAVE BEEN TESTED FOR THE IDENTIFIED FAILURES. NO FURTHER CONSPICUOUS OR FAULTY PLUGS WAS IDENTIFIED. TAKING INTO ACCOUNT THE KNOWN RISK REDUCTION FACTORS (A SECOND SET OF ELECTRODES SHOULD ALWAYS BE AVAILABLE AND THE DAILY DEVICE TEST OF THE DEFIBRILLATOR), A 100% INSPECTION OF THE CABLE PLUGS AT THE SUPPLIER AND A 100% INSPECTION OF THE CABLE PLUGS AT LEONHARD LANG GMBH, WE HAVE CONCLUDED THAT THE RISK OF USING THESE CABLE PLUGS IS ACCEPTABLE. THE SUPPLIER HAS IMPROVED THE ENTIRE SOLDERING PROCESS INCLUDING ALSO THE SOLDERING BUSH. THE EFFECTIVENESS HAS BEEN CONFIRMED WITHIN A CAPA (CAP-23-0213) IN (B)(6) 2024. WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT CLOSED. 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 221019-4015 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON MAY 23RD, 2023 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. ONE 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 WAS WITHIN LIMITS. ANOTHER CONTINUITY TEST WAS PERFORMED TO CHECK CONTINUITY BETWEEN THE TWO PINS OF A RESISTOR IN THE CONNECTOR. THIS TEST REVEALED THAT THE CODING RESISTOR'S VALUE CANNOT BE MEASURED. 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 HAVE NOT BEEN RECOGNIZED BY THE DEFIBRILLATOR. THE DEFIBRILLATOR SHOWED ON THE DISPLAY THE MESSAGE: "CONNECT THERAPY ELECTRODES". WE WILL FURTHER INVESTIGATE THE INVOLVED DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL IN (B)(6). THERE AN X-RAY INVESTIGATION WILL BE CARRIED OUT ON ALL METAL PARTS OF THE DEFIBRILLATION ELECTRODE SET TO DETERMINE IF THERE IS ANY BREAKAGE. ONCE THE RESULTS OF THE X-RAY INVESTIGATION BECOME AVAILABLE WE WILL PROVIDE A FOLLOW-UP REPORT. 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), 2023, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER IN (B)(6). GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECT (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "AT AROUND 0811 HOURS, WHEN AMBULANCE CREW WAS PERFORMING CPR FOR PATIENT AND CHANGED THE DM TO AED MODE, THE PROMPT "CONNECT THERAPY ELECTRODES" APPEARED ON MONITOR SCREEN. AMBULANCE CREW THEN CHECKED IF THE PLUG OF DEFIBRILLATION PADS WAS PROPERLY INSERTED, AND TRIED RE-INSERTING THE PLUG, BUT STILL THE DM COULD NOT PROCEED TO ANALYZE. THE AMBULANCE CREW ALSO CHECKED THE DEFIBRILLATION PADS WERE PROPERLY STICK ON PATIENT'S BODY. THE AMBULANCE CREW THEN REPLACE THE DEFIBRILLATION PAD WITH ANOTHER NEW ONE, AND ANALYSE WAS THEN SUCCESSFUL. THE CONCERNED DEFIBRILLATION PAD WAS CHECKED WITHIN EXPIRY DATE, AND NO VISIBLE DEFECT." WE HAVE REQUESTED FURTHER INFORMATION ON THE INCIDENT AND THE PATIENT OUTCOME. NO FURTHER DETAILS HAVE BEEN DISCLOSED DESPITE REPEATED REQUESTS.
ON (B)(6) 2023, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKOWN USER IN HONG KONG. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECT (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "AT AROUND 0811 HOURS, WHEN AMBULANCE CREW WAS PERFORMING CPR FOR PATIENT AND CHANGED THE DM TO AED MODE, THE PROMPT "CONNECT THERAPY ELECTRODES" APPEARED ON MONITOR SCREEN. AMBULANCE CREW THEN CHECKED IF THE PLUG OF DEFIBRILLATION PADS WAS PROPERLY INSERTED, AND TRIED RE-INSERTING THE PLUG, BUT STILL THE DM COULD NOT PROCEED TO ANALYZE. THE AMBULANCE CREW ALSO CHECKED THE DEFIBRILLATION PADS WERE PROPERLY STICK ON PATIENT'S BODY. THE AMBULANCE CREW THEN REPLACE THE DEFIBRILLATION PAD WITH ANOTHER NEW ONE, AND ANALYSE WAS THEN SUCCESSFUL. THE CONCERNED DEFIBRILLATION PAD WAS CHECKED WITHIN EXPIRY DATE, AND NO VISIBLE DEFECT." WE HAVE REQUESTED FURTHER INFORMATION ON THE INCIDENT AND THE PATIENT OUTCOME. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1956413 | GS | MULTIFUNCTION DEFIBRILLATION ELECTRODE | MKJ | LEONHARD LANG GMBH | DF53NC | 221019-4015 | 19005531505302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |