BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 8711467 · Received June 19, 2019

    Report

    Report Number
    8020045-2019-00015
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    February 22, 2019
    Report Date
    July 31, 2019
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    190005531506385
    PMA / PMN Number
    K142803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE TWO CONCERNED LOT NUMBERS 181114-0772 AND 180625-0778 WERE INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION AND MECHANICALLY. ALL ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE THREE SAMPLES INVOLVED IN THE INCIDENT WERE RETURNED IN A NON STEAM PROOF PE POUCH. THE SAMPLES HAVE BEEN INSPECTED VISUALLY. THE GEL SIDE OF ONE ELECTRODES WAS STUCK TO THE TRANSPARENT LINER AND THE SECOND ELECTRODE TO THE SAME TRANSPARENT LINER ON THE SIDE NOT SILICONIZED. WE WERE ABLE TO SEPERATE THE ELECTRODES FROM THE TRANSPARENT LINER AND PERFORMED FURTHER TESTING FOR ELECTRICALLY CONTINUITY WITH A MULTIMETER. THIS TEST INCLUDED ALL METALL COMPONENTS: THE CONNECTOR, THE CABLE, THE RIVET AND THE ELECTRODE ITSELF. THEREBY NO DEVIATION WAS DETECTED. WE ALSO HAVE PERFORMED FURTHER ELECTRICAL TESTS. ALL THREE INVOLVED DEFIBRILLATION ELECTRODES WERE WITHIN LIMITS DESPITE OF THE CONDITIONS THEY HAD BEEN TRANSPORTED AND STORED. WE HAVE SEND THE THREE INVOLVED SAMPLES (3 SETS OF ELECTRODE PAIRS) TO THE MEDICAL UNIVERSITY INNSBRUCK, DEPARTMENT OF RADIOLOGY FOR AN X-RAY INVESTIGATION TO CHECK FOR HIDDEN DEFECTS OF THE ELECTRODE CABLES. THE X-RAY INVESTIGATION TO VISUALIZE A POSSIBLE FAILURE WITHOUT DESTROYING THE CONNECTOR RESPECTIVELY THE CABLE SHOWED NO DAMAGE OF THE METALLIC CABLE STRANDS OR THE 6 ELECTRODES (3 ELECTRODE PAIRS). AS NO FAILURE COULD BE DETECTED UPON THE ANALYSIS OF THE RETURNED AND INVOLVED SAMPLES NO FURTHER CONCLUSION CAN BE DRAWN AS TO WHAT MIGHT HAVE CAUSED THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 0

    ON (B)(6)2019, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH THREE DEFIBRILLATION ELECTRODE SETS AT (B)(6) HOPITAL(B)(6) FRANCE. SKINTACT DEFIBRILLATION ELECTRODES (MODEL DF27N) AND A PHILIPS HEARTSTART MRX DEFIBRILLATOR HAD BEEN USED. THE COMPLAINANT STATED THAT [TRANSLATED FROM FRENCH TO GERMAN THEN TO ENGLISH]: DEFECTIVE ELECTRODES, NO SIGNAL, THE ELECTRODES WERE TESTED WITH 2 DIFFERENT DEFIBRILLATORS AND 3 DIFFERENT CABLES ["PATCHS TESTÉS AVEC 2 DÉFIBRILLATEURS DIFFÉRENTS ET 3 CABLES DIFFÉRENTS"). IT IS UNCLEAR WHAT "CABLES" MEANS AS NO THERAPY CABLES WERE USED; IT IS POSSIBLE THAT "CABLES" AND ELECTRODES WERE USED AS SYNONYMS. LOTS NO .: 181114-0772 AND 180625-0778 A BIOMEDICINE TECHNICIAN TESTED THE DEFIBRILLATOR AND DID NOT DETECT ANY FAILURE. IN A QUESTIONNAIRE THE USER STATED THAT THE PATIENT WAS BEING TREATED FOR PREVENTION OF CARDIAC ARRHYTHMIAS. THE DURATION OF TREATMENT WAS 1HOUR 30 MINUTES AND THE DURATION OF MONITORING WAS 1HOUR AND 45 MINUTES. THE BODY AND SKIN TYPE OF THE PATIENT WAS DESCRIBED AS NORMAL. THE GENERAL STATE OF THE PATIENT WAS DESCRIBED AS NORMAL. THE SKIN WAS DISINFECTED BY A SHOWER AND BETADINE SCRUB. IT WAS NOT SHAVEN, NOT DRIED AND NO OINTMENT HAD BEEN USED. THE PATIENT WAS LYING ON THE BACK ON THE OPERATING TABLE. THE DEFIBRILLATION ELECTRODES WERE OPENED PRIOR BEFORE USE. THE ELECTRODES WERE ADHERING PROPERLY TO THE PATIENT.. IT WAS FURTHER STATED THAT THERE WAS NO HARM CAUSED TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE TWO CONCERNED LOT NUMBERS 181114-0772 AND 180625-0778 WERE INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION AND MECHANICALLY. ALL ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE THREE SAMPLES INVOLVED IN THE INCIDENT WERE RETURNED IN A NON STEAM PROOF PE POUCH. THE SAMPLES HAVE BEEN INSPECTED VISUALLY. THE GEL SIDE OF ONE ELECTRODES WAS STUCK TO THE TRANSPARENT LINER AND THE SECOND ELECTRODE TO THE SAME TRANSPARENT LINER ON THE SIDE NOT SILICONIZED. WE WERE ABLE TO SEPARATE THE ELECTRODES FROM THE TRANSPARENT LINER AND PERFORMED FURTHER TESTING FOR ELECTRICALLY CONTINUITY WITH A MULTIMETER. THIS TEST INCLUDED ALL METALL COMPONENTS: THE CONNECTOR, THE CABLE, THE RIVET AND THE ELECTRODE ITSELF. THEREBY NO DEVIATION WAS DETECTED. WE ALSO HAVE PERFORMED ELECTRICALLY TESTS. ALL THREE INVOLVED DEFIBRILLATION ELECTRODES WERE WITHIN LIMITS DESPITE OF THE CONDITIONS THEY HAD BEEN TRANSPORTED AND STORED. WE WILL SUBMIT THE THREE RETURNED SAMPLES TO AN X-RAY INVESTIGATION TO CHECK FOR HIDDEN DEFECTS OF THE ELECTRODE CABLES. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE RESULTS. SO FAR, NO CONCLUSION CAN BE DRAWN AS TO WHY THE ELECTRODES DID NOT PROVIDE A SIGNAL TO THE DEFIBRILLATOR.

    Description of Event or Problem · 1

    ON (B)(6) 2019, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH THREE DEFIBRILLATION ELECTRODE SETS AT (B)(6). SKINTACT DEFIBRILLATION ELECTRODES (MODEL DF27N) AND A PHILIPS HEARTSTART MRX DEFIBRILLATOR HAD BEEN USED. THE COMPLAINANT STATED THAT [TRANSLATED FROM (B)(6) TO (B)(6) THEN TO ENGLISH]: DEFECTIVE ELECTRODES, NO SIGNAL, THE ELECTRODES WERE TESTED WITH 2 DIFFERENT DEFIBRILLATORS AND 3 DIFFERENT CABLES ["PATCHS TESTÉS AVEC 2 DÉFIBRILLATEURS DIFFÉRENTS ET 3 CABLES DIFFÉRENTS"). IT IS UNCLEAR WHAT "CABLES" MEANS AS NO THERAPY CABLES WERE USED; IT IS POSSIBLE THAT "CABLES" AND ELECTRODES WERE USED AS SYNONYMS. LOTS NO .: 181114-0772 AND 180625-0778. A BIOMEDICINE TECHNICIAN TESTED THE DEFIBRILLATOR AND DID NOT DETECT ANY FAILURE. IN A QUESTIONNAIRE THE USER STATED THAT THE PATIENT WAS BEING TREATED FOR PREVENTION OF CARDIAC ARRHYTHMIAS. THE DURATION OF TREATMENT WAS 1HOUR 30 MINUTES AND THE DURATION OF MONITORING WAS 1HOUR AND 45 MINUTES. THE BODY AND SKIN TYPE OF THE PATIENT WAS DESCRIBED AS NORMAL. THE GENERAL STATE OF THE PATIENT WAS DESCRIBED AS NORMAL. THE SKIN WAS DISINFECTED BY A SHOWER AND BETADINE SCRUB. IT WAS NOT SHAVEN, NOT DRIED AND NO OINTMENT HAD BEEN USED. THE PATIENT WAS LYING ON THE BACK ON THE OPERATING TABLE. THE DEFIBRILLATION ELECTRODES WERE OPENED PRIOR BEFORE USE. THE ELECTRODES WERE ADHERING PROPERLY TO THE PATIENT. IT WAS FURTHER STATED THAT THERE WAS NO HARM CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504029 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF27N 180625-0778 190005531506385

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other