BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 4319743 · Received November 25, 2014

    Report

    Report Number
    8020045-2014-00014
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    May 22, 2013
    Report Date
    November 25, 2014
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    PMA / PMN Number
    K072233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES AND A RETURNED CUSTOMER SAMPLE OF THE SAME LOT NUMBER WERE INVESTIGATED WITH A TEST GAUGE FOR FIT AND AN ORIGINAL THERAPY CABEL. THE RETAINED SAMPLES SHOWED NO DEVIATION, THE CONNECTORS COULD BE INSERTED IN THE INSPECTION TOOL AND THE THERAPY CABEL EASILY. WHEN TRYING TO INSERT THE RETURNED CUSTOMER SAMPLE INTO THE TEST GAUGE, RESISTANCE WAS MET AND THE INSERTION WAS ONLY POSSIBLE WHEN USING GREATER THAN USUAL FORCE. NO DEVIATION WAS OBSERVED WHEN INSERTING THE RETURNED SAMPLE INTO THE THERAPY CABEL. THE RESISTANCE WAS DETERMINED TO COME FROM THE "HOLDING NOSES". THE OBSERVATION THAT THE STOP WAS PREVENTING THE CONNECTOR FROM GETTING ELECTRICAL CONTACT COULD NOT BE DUPLICATED. THE HOSPITAL PROVIDED A REPORT (EVIDENCING A FRACTURE IN THE SOCKET OF THE THERAPY CABLE, WHICH MIGHT HAVE BEEN RESPONSIBLE FOR THE DIFFICULTY TO OBTAIN AN ELECTRICAL CONNECTION DURING THE INCIDENT. THE FRACTURE HOWEVER, MAY HAVE BEEN CAUSED BY THE USE OF EXCESSIVE FORCE TO INSERT THE CONNECTOR IN THE FIRST PLACE. AFTER INVESTIGATING THIS INCIDENT THE CONNECTOR DESIGN WAS MODIFIED, SPECIFICALLY THE GEOMETRY OF THE TWO HOLDING NOSES ON ONE SIDE WAS MODIFIED TO PRESENT AN INCLINATION TOWARDS THE SOCKET TO FACILITATE INSERTION. THE REVISION OF THE CONNECTOR INVOLVED IN THE INCIDENT IN (B)(6) WAS NEVER MARKETED IN THE US. ONLY A LATER REVISION ALREADY INCORPORATING THE IMPROVED GEOMETRY WAS. THE FIRST LOT SHIPPED INTO THE US WAS 41009-0975 MANUFACTURED IN 10/2014. DURING AN FDA AUDIT FROM (B)(4) 2014 IT WAS DETERMINED THAT WE FAILED TO REPORT THIS MALFUNCTION TO THE FDA AT THE TIME. ALTHOUGH THIS PARTICULAR CABLE AND CONNECTOR HAVE NEVER BEEN MARKETED IN THE USE, THE PRODUCT COULD BE COVERED UNDER AN EXISTING 510K BY MEANS OF A LETTER TO FILE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 WE HAVE BEEN INFORMED OF A MALFUNCTION IN (B)(6). OUR CUSTOMER REPORTED THAT DURING A TREATMENT OF A PT IN THE CORONAROGRAPHY UNIT IT WAS NECESSARY O PLACE DEFIBRILLATION ELECTRODES ON THE PT'S CHEST. WHEN TRYING TO INSERT THE CONNECTOR OF THE DEFIBRILLATION ELECTRODES INTO THE SOCKET OF A THERAPY CABLE (M3508A, MANUFACTURED IN 01/2003) CONNECTED TO A DEFIBRILLATOR HEARTSTART XL (M4735A) IT WAS NOT POSSIBLE TO DO SO. THE OPERATOR CLIPPED OUTSIDE ELEMENTS (SEE DETAILS BELOW) OF THE CONNECTOR WITH SCISSORS AND WAS THEN ABLE TO INSERT THE CONNECTOR INTO THE SOCKET TO OBTAIN AN ECG READING SUCCESSFULLY. DETAILS: AT FIRST THEY CLIPPED PLASTIC "HOLDING NOSES" ON THE OUTSIDE SURFACE OF THE CONNECTOR. THESE CYLINDRICAL ELEMENTS ARE SUPPOSED TO FIX THE CONNECTOR IN THE SOCKET TO PREVENT IT FROM GETTING LOOSE. AS THEY STILL COULD NOT GET AN ECG SIGNAL, THEY THEN CLIPPED A STILL COULD NOT GET AN ECG SIGNAL, THEY THEN CLIPPED A SECOND ELEMENT, A STOP ON THE OUTSIDE SURFACE, WHICH LIMITS THE DISTANCE THE CONNECTOR CAN BE INSERTED INTO THE SOCKET. IT WAS ALSO REPORTED BY THE HOSPITAL THAT THIS MALFUNCTION HAD NO IMPACT ON THE PT AS NO DEFIBRILLATION WAS REQUIRED. REMARK: THERE IS AN AMBIGUITY ABOUT THE ACTUAL DATE OF THE INCIDENT. THE REPORTER PROVIDED BOTH, (B)(6). WE HAVE DECIDED TO USE (B)(6) AS IT APPEARS TO BE MORE PLAUSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766624 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTR. MKJ LEONHARD LANG GMBH DF27N 30123-0775

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other