SKINTACT
Report
- Report Number
- 8020045-2024-00020
- Event Type
- Malfunction
- Date Received
- October 17, 2024
- Report Date
- March 18, 2025
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- MKJ
- UDI-DI
- 19005531506385
- PMA / PMN Number
- K142803
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- 501
Narratives
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 NUMBERS HAVE BEEN INSPECTED VISUALLY. ELECTRICAL TESTS WERE PERFORMED ON RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. WE HAVE RECEIVED ON (B)(6) THE INVOLVED DEVICE IN THE INCIDENT IN AN OPEN POUCH. IT WAS DISINFECTED AND THEN INSPECTED. THE INVOLVED DEVICE IN THE INCIDENT SHOWED THE LOT NUMBER 240506-0772. HOWEVER, LOT NUMBER 240314-4045 WAS INITIALLY REPORTED AS INVOLVED. THE POUCH OF THE RETURNED ELECTRODE SET HAD ALREADY BEEN OPENED AND THE ELECTRODES WERE GLUED TOGETHER GEL TO GEL SIDE. AFTER REVIEWING THE RETURNED CUSTOMER SAMPLE, WE CONCLUDED THAT THE INVOLVED DEVICE IN THE INCIDENT HAD NEVER BEEN APPLIED TO A PATIENT. THIS CAN BE SEEN THAT NO MARKS, RESIDIUES OR A CONTAMINATION WITH SKIN PARTICLES OR PATIENT HAIR WAS VISIBLE. WE HAVE CONNECTED THE INVOLVED DEVICE IN THE INCIDENT TO A PHILIPS HEARTSTART MRX AND HAVE APPLIED THE DEFIBRILLATION ELECTRODES TO THE TEST DEVICE FLUKE IMPULSE 7000DP TO SIMULATE A VENTRICULAR FIBRILLATION. THE PHILIPS HEARTSTART MRX WAS ABLE TO PERFORM AN ECG DIAGNOSIS AND RECOMMENDED A SHOCK. SIX SHOCKS WERE SUCCESSFULLY DELIVERED. THE DF27N DEFIBRILLATION ELECTRODE IS AN IN-POUCH ELECTRODE, WHICH MEANS THAT IT CANNOT BE PRE-CONNECTED FOR A DEFIBRILLATOR SELF-TEST. IN THE IFU, IT IS POINTED OUT THAT THE ELECTRODES SHOULD ONLY BE OPENED IMMEDIATELY BEFORE USE WHEN USING THE ELECTRODE AS INTENDED! THE DF27N SHOULD BE CARRIED UNOPENED WITH THE AED AND, WHEN NEEDED, TORN OPEN, APPLIED TO THE PATIENT AND CONNECTED TO THE DEFIBRILLATOR. PRE-CONNECTING THE DF27N IS NOT INTENDED OR POSSIBLE DUE TO THE DESIGN OF THE DEFIBRILLATION ELECTRODE AND WOULD LEAD TO THE ELECTRODE DRYING OUT. IT IS NOT POSSIBLE TO CHECK THE DEFIBRILLATION ELECTRODE USING A SELF-TEST WITH THIS ELECTRODE MODEL. HOWEVER, THIS DOES NOT MEAN THAT ITS FUNCTION IS NOT GUARANTEED BUT THE ELECTRODES HAVE TO BE APPLIED TO THE PATIENT THAT THE DEFIBRILLATOR RECOGNIZES A PATIENT HEART RHYTHM AND TO GO AHEAD IN PROCEDURE. HOWEVER, SOME STATEMENTS OF THE USER ARE STILL UNCLEAR ("THIS WAS NOT THE CASE WITH THE NEW PACK"). UPDATE ON SITE MEETING (B)(6) HOSPTIAL WITH THE COMPLAINING SENIOR PHYSICIAN, THE DEFIBRILLATION PRODUCT SPECIALIST FROM LEONHARD LANG AND THE LEONHARD LANG FIELD SALES REPRESENTATIVE. AFTER THE MEETING A VISIT PROTOCOL WAS CREATED AND SEND OUT FOR CONFIRMING THE INVESTIGATION RESULTS. IT WAS STATED WIHIN THE PROTOCOL [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE]: "DURING OUR VISIT TO EMERGENCY MEDICINE 6D ON (B)(6) 2025, AT 11:45 A.M., THE DEVICE INVOLVED IN THE INCIDENT (SKINTACT DF27N DEFIBRILLATION ELECTRODE WITH LOT NUMBER 240506-0772) WAS THOROUGHLY EXAMINED AND TESTED WITH A PHILIPS MRX DEFIBRILLATOR. THE REPORTED ERROR MESSAGE "NO RHYTHM / CONNECT DEFIBRILLATION PADS" IN MANUAL DEFIBRILLATOR MODE COULD NOT BE REPRODUCED. THE DEVICE FUNCTIONED PERFECTLY IN THIS MODE WITH THE DEVICE INVOLVED IN THE INCIDENT. PACER MODE AND AED MODE WERE ALSO CHECKED, AND IN BOTH CASES, NEITHER THE DESCRIBED ERROR MESSAGE NOR ANY OTHER ERROR MESSAGES OR ABNORMALITIES WERE DETECTED. FOR FURTHER ASSURANCE, AN ORIGINAL PHILIPS SMARTPADS II ELECTRODE WAS ALSO TESTED. THE PHILIPS MRX SHOWED NO DEVIATIONS OR ERROR MESSAGES. THE ELECTRODE IN QUESTION AND THE ORIGINAL ELECTRODE PRODUCED IDENTICAL POSITIVE RESULTS, AND THE DEFIBRILLATOR OPERATED FLAWLESSLY IN ALL MODES WITH BOTH ELECTRODE SETS. BASED ON THESE COMPREHENSIVE INVESTIGATIONS, NO TECHNICAL IRREGULARITIES OR QUALITY DEVIATIONS WERE FOUND WITH THE DEVICE INVOLVED IN THE INCIDENT. NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CUSTOMER PROBLEM. 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 NUMBERS HAVE BEEN INSPECTED VISUALLY. ELECTRICAL TESTS WERE PERFORMED ON RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. WE HAVE RECEIVED ON SEPTEMBER 30TH THE INVOLVED DEVICE IN THE INCIDENT IN AN OPEN POUCH. IT WAS DISINFECTED AND THEN INSPECTED. THE INVOLVED DEVICE IN THE INCIDENT SHOWED THE LOT NUMBER 240506-0772. HOWEVER, LOT NUMBER 240314-4045 WAS INITIALLY REPORTED AS INVOLVED. THE POUCH OF THE RETURNED ELECTRODE SET HAD ALREADY BEEN OPENED AND THE ELECTRODES WERE GLUED TOGETHER GEL TO GEL SIDE. AFTER REVIEWING THE RETURNED CUSTOMER SAMPLE, WE CONCLUDED THAT THE INVOLVED DEVICE IN THE INCIDENT HAD NEVER BEEN APPLIED TO A PATIENT. THIS CAN BE SEEN THAT NO MARKS, RESIDIUES OR A CONTAMINATION WITH SKIN PARTICLES OR PATIENT HAIR WAS VISIBLE. WE HAVE CONNECTED THE INVOLVED DEVICE IN THE INCIDENT TO A PHILIPS HEARTSTART MRX AND HAVE APPLIED THE DEFIBRILLATION ELECTRODES TO THE TEST DEVICE FLUKE IMPULSE 7000DP TO SIMULATE A VENTRICULAR FIBRILLATION. THE PHILIPS HEARTSTART MRX WAS ABLE TO PERFORM AN ECG DIAGNOSIS AND RECOMMENDED A SHOCK. SIX SHOCKS WERE SUCCESSFULLY DELIVERED. THE DF27N DEFIBRILLATION ELECTRODE IS AN IN-POUCH ELECTRODE, WHICH MEANS THAT IT CANNOT BE PRE-CONNECTED FOR A DEFIBRILLATOR SELF-TEST. IN THE IFU, IT IS POINTED OUT THAT THE ELECTRODES SHOULD ONLY BE OPENED IMMEDIATELY BEFORE USE WHEN USING THE ELECTRODE AS INTENDED! THE DF27N SHOULD BE CARRIED UNOPENED WITH THE AED AND, WHEN NEEDED, TORN OPEN, APPLIED TO THE PATIENT AND CONNECTED TO THE DEFIBRILLATOR. PRE-CONNECTING THE DF27N IS NOT INTENDED OR POSSIBLE DUE TO THE DESIGN OF THE DEFIBRILLATION ELECTRODE AND WOULD LEAD TO THE ELECTRODE DRYING OUT. IT IS NOT POSSIBLE TO CHECK THE DEFIBRILLATION ELECTRODE USING A SELF-TEST WITH THIS ELECTRODE MODEL. HOWEVER, THIS DOES NOT MEAN THAT ITS FUNCTION IS NOT GUARANTEED BUT THE ELECTRODES HAVE TO BE APPLIED TO THE PATIENT THAT THE DEFIBRILLATOR RECOGNIZES A PATIENT HEART RHYTHM AND TO GO AHEAD IN PROCEDURE. HOWEVER, SOME STATEMENTS OF THE USER ARE STILL UNCLEAR ("THIS WAS NOT THE CASE WITH THE NEW PACK"). THE INVESTIGATION WILL BE CONTINUED AND A FOLLOW-UP REPORT WILL BE PROVIDED.
ON SEPTEMBER 19TH, 2024 WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT EMERGENCY MEDICINE UNIT INTENSIVE CARE WIENER GESUNDHEITSVERBUND-AKH-BA 10 IN AUSTRIA. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF27N AND AN UNKNOWN DEFIBRILLATOR HAD BEEN USED. THE COMPLAINANT REPORTED [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE] "WHEN USING THE DEFIBRILLATOR PADS, THE MESSAGE ON THE DEFIBRILLATOR DEVICE APPEARED AFTER CONNECTING THEM: "NO RHYTHM / CONNECT DEFIBRILLATOR PAD" (WAS DISPLAYED ALTERNATELY). THIS WAS NOT THE CASE WITH THE NEW PACK. THE DEFIBRILLATOR WAS THEN CHECKED TO ENSURE IT WAS WORKING PROPERLY. THE QUICK TEST OF THE DEVICE ALSO DID NOT PRODUCE ANY ERROR MESSAGES." WE HAVE REQUESTED FURTHER INFORMATION AND THE CONCERNED DEFIBRILLATION SET FOR FURTHER INVESTIGATION.
ON (B)(6) 2024 WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT EMERGENCY MEDICINE UNIT INTENSIVE CARE WIENER GESUNDHEITSVERBUND-AKH-BA 10 IN AUSTRIA. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF27N AND AN UNKNOWN DEFIBRILLATOR HAD BEEN USED. THE COMPLAINANT REPORTED [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE] "WHEN USING THE DEFIBRILLATOR PADS, THE MESSAGE ON THE DEFIBRILLATOR DEVICE APPEARED AFTER CONNECTING THEM: "NO RHYTHM / CONNECT DEFIBRILLATOR PAD" (WAS DISPLAYED ALTERNATELY). THIS WAS NOT THE CASE WITH THE NEW PACK. THE DEFIBRILLATOR WAS THEN CHECKED TO ENSURE IT WAS WORKING PROPERLY. THE QUICK TEST OF THE DEVICE ALSO DID NOT PRODUCE ANY ERROR MESSAGES." WE HAVE REQUESTED FURTHER INFORMATION AND THE CONCERNED DEFIBRILLATION SET FOR FURTHER INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1463517 | SKINTACT | MULTIFUNCTION DEFIBRILLATION ELECTRODE | MKJ | LEONHARD LANG GMBH | DF27N | 240314-40452 | 19005531506385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |