SKINTACT
Report
- Report Number
- 8020045-2024-00011
- Event Type
- Malfunction
- Date Received
- May 13, 2024
- Report Date
- June 6, 2024
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- MKJ
- UDI-DI
- 19005531502912
- PMA / PMN Number
- K142803
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 501
Narratives
RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. REVIEWING THE RETAINED POUCH SAMPLE PRINTING NO FAULTS CONCERNING THE PRINTING SPECIFICATIONS CAN BE OBSERVED. THE POUCH OF THE CONCERNED LOT NUMBER: 231023-4013 IS SHOWING ON THE FRONT SIDE THE LIST OF COMPATIBLE DEFIBRILLATORS. THE USAGE OF THE CONCERNED ELECTRODE LOT NUMBER: 231023-4013 IS COMPATIBLE WITH THE FOLLOWING DEFIBRILLATORS: "ONLY USE WITH PHYSIO CONTROL". ON APRIL 11TH, 2024 WE RECEIVED A BOX WITH 10 ORIGINAL CLOSED DEFIBRILLATION SETS FROM THE SAME LOT NUMBER. THE INVOLVED DEVICE WAS NOT AVAILBALE FOR FURTHER INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED CUSTOMER DEFIBRILLATION ELECTRODE SETS SHOWED NO OBVIOUS DAMAGE. THE CONNECTORS OF THE RETURNED CUSTOMER ELECTRODE SETS WERE ALSO VISUALLY INSPECTED. NEITHER DAMAGES NOR DEVIATIONS WERE VISIBLE. AFTERWARDS AN ELECTRICAL PERFORMANCE TEST WAS CARRIED ON. THE RETURNED CUSTOMER ELECTRODE SETS HAVE BEEN ADHERED ONTO THE DEFIBRILLATION TEST EQUIPMENT FLUKE IMPULSE 7000DP AND CONNECTED TO A LIFEPACK 20E C3 DEFIBRILLATOR. THE LIFEPACK 20E 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 WITH THE MANUAL AND ALSO IN THE AED MODE. THE USER WAS DEVIATING FROM THE SPECIFICATIONS USING THE ELECTRODE SET WITH AN INCOMPATIBEL MINDRAY BENEHEART D6 DEFIBRILLATOR. THE IFU SPECIFIES: "THE ELECTRODES MUST ONLY BE USED BY APPROPRIATELY QUALIFIED MEDICAL PERSONNEL, WHO HAVE BEEN TRAINED IN HOW TO USE THEM BASED ON THESE INSTRUCTIONS FOR USE. (...) COMPATIBILITY USE THESE ELECTRODES ONLY WITH COMPATIBLE DEFIBRILLATORS AS LISTED ON THE PACKAGING. USE OF THIS PRODUCT WITH ANY DEVICE NOT LISTED MAY RESULT IN POTENTIALLY HAZARDOUS CONNECTION." THE POUCH CLEARLY STATES THE COMPATIBILITY: "ONLY USE WITH PHYSIO CONTROL" AND "COMPATIBLE WITH PHYSIO-CONTROL LIFEPAK 12, 15, 20, 20E, 500, 1000". WE ASSUME THE USER HAS CAUSED OR CONTRIBUTED TO THE CLAIMED INCIDENTS BY USING THE ELECTRODES WITH A NON-COMPATIBEL DEFIBRILLATOR. WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT CLOSED.
RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. ON APRIL 11TH, 2024 WE RECEIVED A BOX WITH 10 ORIGINAL CLOSED DEFIBRILLATION SETS FROM THE SAME LOT NUMBER. THE INVOLVED DEVICE WAS NOT AVAILBALE FOR FURTHER INVESTIGATION. A VISUAL INSPECTION OF THE DEFIBRILLATION ELECTRODE SETS SHOWED NO OBVIOUS DAMAGE. CURRENTLY ELECTRICALLY INVESTIGATIONS ARE CARRIED OUT TO TEST THE CUSTOMER SAMPLES. AT THE MOMENT NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. WE HAVE REQUESTED FURTHER INFORMATION AND WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE FURTHER RESULTS.
ON APRIL 02ND, 2024, WE HAVE BEEN INFORMED ABOUT A PRODUCT PROBLEM. THE INITIAL REPORTER SPECIFIED THAT "ONE OF OUR CLIENT IS RETURNING US DF20NC LOT 231023-4013. THOSE ARE HAVING DIFFICULTIES IN DELIVERING A CHOC AND USER NEED TO DEFIBRILLATE MORE THAN ONCE" AFTER REQUESTING FURTHER INFORMATION WE LEARNED ON APRIL 18TH, 2024: "THE ELECTRODE HAS BEEN RECOGNIZED, (...) IT IS NOT A CONNECTION PROBLEM (...) EXACT THE 1ST CHOCK WAS NOT DELIVERED BUT THEN IT WAS WORKING" BASED ON THIS INFORMATION PROVIDED ON APRIL 18TH, 2024 WE HAVE ESTIMATED A PRODUCT MALFUNCTION HAS HAPPEND AND THEREFORE ALSO A REPORTABLE EVENT HAS HAPPENED. WE HAVE RECEIVED A PARTIALLY FILLED IN QUESTIONNAIRE IN FRENCH LANGUAGE. THE QUESTIONNAIRE [TRANSLATED FROM FRENCH LANGUAGE TO GERMAN LANGUAGE TO ENGLISH LANGUAGE] IS SPECIFYING FOR THE INCIDENT DATE "MULTIPLE" INCIDENTS. THE FILLED IN QUESTIONNAIRE IS ALSO STATING THAT "DURING AN ABLATION OF VENTRICULAR TACHYCARDIA (VT) AND SEVERAL OTHER ABLATIONS (ATRIAL FIBRILLATION), DEFIBRILLATION FAILED AT 200J FOR NO APPARENT REASON." THE DURATION OF THE PROCEDURES HAVE BEEN DISCLOSED AS 2 - 3 HOURS. THE USER WAS SPECIFYING THAT THE PACKAGED ELECTRODES ARE STORED IN THE OPERATING ROOM. NO ADDITIONAL GEL WAS USED AND NO SHOCK WAS DELIVERED WITH DEFIBRILLATION PADDLES. A MINDRAY BENEHEART D6 DEFIBRILLATOR WAS USED IN A BIPHASIC MANUAL MODE. THE CONCERNED PATIENTS HAVE BEEN DESCRIBED AS 50-75 YEARS OLD AND APPROXIMATELY OF 70KG WEIGHT. THE PATIENTS WERE DESCRIBED AS NORMAL BUILT. THE PATIENT SKIN WAS NORMAL AND NOT HAIRY. THE PATIENT SKIN WAS CLEANED WITH BETADINE AND SHAVEN PRIOR APPLYING THE DEFIBRILLATION ELECTRODE. IT WAS NOT DRIED, NOT DISINFECTED AND NO LOTIONS OR CREAMS HAVE BEEN USED. FURTHER ON IT WAS REPORTED THAT THE DEFIBRILLATION ELECTRODES ADHERED WELL TO THE PATIENT SKIN. THE DEFIBRILLATION ELECTRODES HAVE BEEN APPLIED ANTERIOR AND POSTERIOR . NO PATIENT INJURY OR CONSEQUENCE FOR THE PATIENT HEALTH WAS REPORTED. THEREFORE NO TREATMENT WAS NECESSARY. NO FURTHER DETAILS HAVE BEEN DISCLOSED.
ON APRIL 02ND, 2024, WE HAVE BEEN INFORMED ABOUT A PRODUCT PROBLEM. THE INITIAL REPORTER SPECIFIED THAT "ONE OF OUR CLIENT IS RETURNING US DF20NC LOT 231023-4013. THOSE ARE HAVING DIFFICULTIES IN DELIVERING A CHOC AND USER NEED TO DEFIBRILLATE MORE THAN ONCE" AFTER REQUESTING FURTHER INFORMATION WE LEARNED ON APRIL 18TH, 2024: "THE ELECTRODE HAS BEEN RECOGNIZED. IT IS NOT A CONNECTION PROBLEM. EXACT THE 1ST CHOCK WAS NOT DELIVERED BUT THEN IT WAS WORKING" BASED ON THIS INFORMATION PROVIDED ON APRIL 18TH, 2024 WE HAVE ESTIMATED A PRODUCT MALFUNCTION HAS HAPPEND AND THEREFORE ALSO A REPORTABLE EVENT HAS HAPPENED. WE ALSO HAVE RECEIVED A PARTIALLY FILLED IN QUESTIONAIRE IN FRENCH LANGUAGE. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE FINALLY INVESTIGATED AND WE HAVE REACHED A CONCLUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 843127 | SKINTACT | MULTIFUNCTION DEFIBRILLATION ELECTRODE | MKJ | LEONHARD LANG GMBH | DF20NC | 231023-4013 | 19005531502912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |