BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 9353227 · Received November 21, 2019

    Report

    Report Number
    8020045-2019-00027
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 18, 2019
    Report Date
    December 3, 2019
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    190005531506388
    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 CONCERNED LOT NUMBER 190717-4041 WERE INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION AND MECHANICALLY. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE SAMPLE INVOLVED IN THE INCIDENT WAS RETURNED IN A NON STEAM PROOF PE POUCH. THE TWO ELECTRODE PADS (APEX AND STERNUM ELECTRODE) WERE STUCK TOGETHER GEL TO GEL. WE WERE ABLE TO SEPERATE THE ELECTRODES FROM EACH OTHER. THE SEPERATED APEX AND STERNUM ELECTRODE HAD BEEN INSPECTED VISUALLY AND FURTHER TESTED 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 WITH A DEFIBRILLATOR TEST SET UP. NO FAULTS COULD BE OBSERVED. NO FURTHER CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE INCIDENT WE THEREFORE WILL CLOSE THE INVESTIGATION AND THE REPORT.

    Description of Event or Problem · 0

    ON (B)(6)2019, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKOWN HOSPITAL IN FRANCE. A CARDIOVERSION WAS PERFORMED. SKINTACT DEFIBRILLATION ELECTRODES (MODEL DF27N) AND A PHILIPS HEARTSTART XL DEFIBRILLATOR HAD BEEN USED. WE RECEIVED A PARTIALLY FILLED IN QUESTIONNAIRE WHICH IS STATING "5 DEFIBRILLATION ATTEMPTS, THE ELECTRODES DID NOT WORK. 3 TRIALS WITH THE SAME ELECTRODES BUT ANOTHER DEFIBRILLATOR, THE ELECTRODES DID NOT WORK. CHANGING THE ELECTRODES => DEFIBRILLATION OK". IT WAS ALSO REPORTED THAT THE DEFIBRILLATOR WAS USED IN BIPHASIC MODE AND THE USED PROGRAM WAS SPECIFIED AS MANUAL. THE PATIENT WAS LYING IN DORSAL POSTION AND THE SKIN WAS NOT SHAVEN, NOT DESINFECTED, NOT CLEANED AND THE SKIN WAS NOT WET OR MOISTENED. THE PATIENT WAS NOT REPOSITIONED. NO IMPAIRMENTS WERE DETECTABLE BEFORE ATTACHING THE ELECTRODE. NO PATIENT WAS HARMED IN THE INCIDENT.

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER 190717-4041 WERE INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION AND MECHANICALLY. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE SAMPLE INVOLVED IN THE INCIDENT WAS RETURNED IN A NON STEAM PROOF PE POUCH. THE TWO ELECTRODE PADS (APEX AND STERNUM ELECTRODE) WERE STUCK TOGETHER GEL TO GEL. WE WERE ABLE TO SEPARATE THE ELECTRODES FROM EACH OTHER. THE SEPARATED APEX AND STERNUM ELECTRODE HAD BEEN INSPECTED VISUALLY AND FURTHER TESTED FOR ELECTRICALLY CONTINUITY WITH A MULTIMETER. THIS TEST INCLUDED ALL METAL COMPONENTS: THE CONNECTOR, THE CABLE, THE RIVET AND THE ELECTRODE ITSELF. THEREBY NO DEVIATION WAS DETECTED. WE ALSO HAVE PERFORMED FURTHER ELECTRICAL TESTS WITH A DEFIBRILLATOR TEST SET UP. NO FAULTS COULD BE OBSERVED. WE ARE AWAITING FURTHER INFORMATION FROM THE USER REGARDING THE USED DEFIBRILLATOR MAKE AND MODEL. WE ALSO HAVE ASKED, WHICH FAILURE MESSAGE THE DEFIBRILLATOR WAS ISSUING WHEN THE MALFUNCTION OCCURED. CURRENTLY NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE INCIDENT.

    Description of Event or Problem · 1

    ON OCTOBER 25TH, 2019, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN HOSPITAL IN (B)(6). A CARDIOVERSION WAS PERFORMED. SKINTACT DEFIBRILLATION ELECTRODES (MODEL DF27N) AND AN UNKNOWN DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT STATED THAT [TRANSLATED FROM (B)(6) TO (B)(6) THEN TO ENGLISH]: "ELECTRIC SHOCK WITH DEFIBRILLATOR IN SEMI AUTOMATIC MODE NOT FEASIBLE. DEFIBRILLATOR CHANGE: NOT FEASIBLE. CHANGE OF DEFIBRILLATION ELECTRODES: SHOCK OK. ELECTRODES PROBABLY DEFECTIVE." NO PATIENT WAS HARMED IN THE INCIDENT. NO FURTHER DETAILS ON THE MALFUNCTION AND THE DEFIBRILLATOR MODEL HAVE BEEN DISCLOSED SO FAR DESPITE REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146379 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF27N 190717-4041 190005531506388

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O