GS
Report
- Report Number
- 8020045-2023-00009
- Event Type
- Malfunction
- Date Received
- April 12, 2023
- Date of Event
- March 9, 2023
- Report Date
- May 17, 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 220829-4019 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON (B)(6) 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. 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. WE 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. NO CABLE BREAK OR LOOSE CONTACT 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. WE ALSO 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. 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.
RETAINED SAMPLES OF THE CONCERNED LOT NUMBER 220829-4019 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON (B)(6) 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. 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 CORPUS 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. AS NO FAILURE COULD BE DETECTED AT THE INVOLVED CUSTOMER SAMPLE WE THEREFORE WILL FURTHER INVESTIGATE THE INVOLVED DEFIBRILLATION ELECTRODE SET AT UNIVERSITY HOSPITAL IN INNSBRUCK. THEREBY AN X-RAY INVESTIGATION WILL BE CARRIED OUT ON ALL METAL PARTS OF THE DEFIBRILLATION ELECTRODE SET. WE ALSO HAVE REQUESTED THE DATA THE DEFIBRILLATOR HAD RECORDED DURING THE PROCEDURE. ONCE THE INFORMATION ON THE X-RAY AND THE RECORDED DEFIBRILLATOR DATA BECOMES AVAILABLE WE WILL PROVIDE A FOLLOW-UP REPORT. SO FAR, NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM.
ON MARCH 13TH, 2023, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT FIRE RESCUE SERVICE (FEUERWEHR RHEINE) IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53NC) AND A GS CORPULS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT [TRANSLATED FROM GERMAN TO ENGLISCH LANGUAGE] "PRIMARY BRADYCARDIA PATIENT (DIAGNOSTICALLY ALREADY 4-CHANNEL AND 12-CHANNEL ECG PRESENT) IN THE FURTHER COURSE OF THE DISEASE REQUIRED RESUSCITATION. DEFI PATCHES UNPACKED AND GLUED. ANALYSIS MANUALLY - PEA. VENTRICULAR FIBRILLATION AFTER SEVERAL DOSES OF SUPRA. TRYING TO LOAD THE DEFI - MESSAGE ATTACH DEFI PATCHES - THEY WERE ATTACHED...; CONTINUE WITH HDM ; UNPLUGGED AND PLUGGED IN AGAIN - THE QUESTION OF WHETHER A TEST APPLICATION SHOULD BE CREATED -> NO; AFTER THAT, THE SHOCK COULD ALSO BE UPLOADED AND TRIGGERED. SAME PROBLEM AGAIN IN THE RECEIVING HOSPITAL...ALL ASSOCIATED DATA IS READ OUT FROM THE DEVICE, PRINTED OUT AND SAVED. ALSO THE USED DEFI PATCHES INCLUDING THE ORIGINAL PACKAGING." WE HAVE RECEIVED A PARTIALLY FILLED IN QUESTIONNAIRE STATING THAT THE PATIENT BODY TYPE WAS SLIM AND THE SKIN TYPE WAS DESCRIBED AS NORMAL WITH LITTLE BODY HAIR. THE GENERAL CONDITION OF THE PATIENT'S SKIN AT THE TIME OF THE INCIDENT WAS COLD SWEATING. THE PATIENT WAS NOT SHAVEN, NO OINTMENT HAS BEEN APPLIED BUT THE SKIN WAS DRIED PRIOR APPLICATION WITH THE PATIENT T-SHIRT. THE RESUSCITATION LASTED FOR 57 MINUTES. ONE SHOCK WITH 200J WAS DELIVERED TO THE PATIENT. WE HAVE REQUESTED FURTHER INFORMATION. NO FURTHER DETAILS HAVE BEEN DISCLOSED.
ON (B)(6) 2023, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT FIRE RESCUE SERVICE (FEUERWEHR RHEINE) IN GERMANY. GS DEFIBRILLATION ELECTRODES CATALOGUE NUMBER 05120.1 CORPATCH EASY PRE-CONNECTED (MODEL DF53NC) AND A GS CORPUS DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE] "PRIMARY BRADYCARDIA PATIENT (DIAGNOSTICALLY ALREADY 4-CHANNEL AND 12-CHANNEL ECG PRESENT) IN THE FURTHER COURSE OF THE DISEASE REQUIRED RESUSCITATION. DEFI PATCHES UNPACKED AND GLUED. ANALYSIS MANUALLY - PEA. VENTRICULAR FIBRILLATION AFTER SEVERAL DOSES OF SUPRA. TRYING TO LOAD THE DEFI - MESSAGE ATTACH DEFI PATCHES - THEY WERE ATTACHED...; CONTINUE WITH HDM ; UNPLUGGED AND PLUGGED IN AGAIN - THE QUESTION OF WHETHER A TEST APPLICATION SHOULD BE CREATED -> NO; AFTER THAT, THE SHOCK COULD ALSO BE UPLOADED AND TRIGGERED. SAME PROBLEM AGAIN IN THE RECEIVING HOSPITAL...ALL ASSOCIATED DATA IS READ OUT FROM THE DEVICE, PRINTED OUT AND SAVED. ALSO THE USED DEFI PATCHES INCLUDING THE ORIGINAL PACKAGING." WE HAVE RECEIVED A PARTIALLY FILLED IN QUESTIONNAIRE STATING THAT THE PATIENT BODY TYPE WAS SLIM AND THE SKIN TYPE WAS DESCRIBED AS NORMAL WITH LITTLE BODY HAIR. THE GENERAL CONDITION OF THE PATIENT'S SKIN AT THE TIME OF THE INCIDENT WAS COLD SWEATING. THE PATIENT WAS NOT SHAVEN, NO OINTMENT HAS BEEN APPLIED BUT THE SKIN WAS DRIED PRIOR APPLICATION WITH THE PATIENT T-SHIRT. THE RESUSCITATION LASTED FOR 57 MINUTES. ONE SHOCK WITH 200J WAS DELIVERED TO THE PATIENT. WE HAVE REQUESTED FURTHER INFORMATION. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2283657 | GS | MULTIFUNCTION DEFIBRILLATION ELECTRODE | MKJ | LEONHARD LANG GMBH | DF53NC | 220829-4019 | 19005531505302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Other |