BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE STEP COMPLETE ELECTRODES

    MDR report key: 6955234 · Received October 17, 2017

    Report

    Report Number
    1218058-2017-00107
    Event Type
    Death
    Date Received
    October 17, 2017
    Date of Event
    September 20, 2017
    Report Date
    September 26, 2017
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL ELECTRODE PADS USED DURING THE REPORTED EVENT WERE NOT RECEIVED FOR EVALUATION AS PART OF THIS INVESTIGATION. THE CUSTOMER'S REMAINING STOCK OF THE SUSPECTED LOTS WERE FORWARDED TO ZOLL FOR EVALUATION. ADDITIONALLY 35 SETS OF ELECTRODES FROM ZOLL'S FINISHED GOODS AREA WERE TESTED. THE ELECTRODE WERE TESTED SIMULATING 2015 AHA GUIDELINES AT VARIOUS LENGTHS OF TIME WITH THE ELECTRODES ATTACHED TO A MANIKIN IN CONFIGURATIONS IDENTIFIED IN THE IFU. THIS TEST WAS REPEATED USING THE 35 SETS OF ELECTRODES RETURNED FROM THE CUSTOMER. THERE WERE NO IDENTIFIED DIFFERENCES BETWEEN THE LOTS PULLED FROM FINISHED GOODS AND THE LOTS RETURNED FROM THE CUSTOMER. THERE WERE NO ABNORMALITIES, NON-CONFORMANCES, GEL ROLLING OR ELECTRODES SLIDING OBSERVED DURING OUR TESTING. THIS INVESTIGATION PROMPTED AN ONSITE VISIT BY ZOLL'S CLINICAL TEAM TO THE CUSTOMER'S SITE. THE FINDINGS WERE THAT THE STAFF DOES NOT FEEL THEIR CLINICAL TEAMS HAVE THE APPROPRIATE LEVEL OF DEVICE KNOWLEDGE. OBSERVATIONS INCLUDED STAFF REMOVING THE ELECTRODES INCORRECTLY FROM THE RELEASE LINER, NOT SEPARATING THE PADS FROM THE CENTRAL WIRING, NOT UNDERSTANDING THAT THE PUCK CAN BE REMOVED FROM IT'S ORIGINAL LOCATION, AND APPLYING ELECTRODES WITH ONLY THE GEL PORTION OF THE SKIN WITH THE FOAM EDGES OFF THE SKIN. HOWEVER, BASED ON OUR INVESTIGATION RESULTS, A DEFINITIVE DETERMINATION COULD NOT BE MADE AS TO WHY THE GEL WAS ROLLING AND SLIDING WHILE IN CLINICAL USE. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A (B)(6) YEAR OLD MALE PATIENT, THE ELECTRODE PADS WOULD NOT ADHERE APPROPRIATELY AND THE ASSOCIATED DEFIBRILLATOR DID NOT DISPLAY AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE CLINICIAN REPLACED THE PADS WITH ANOTHER SET OF PADS BUT THEY WERE STILL UNABLE TO SEE ANY ECG RHYTHM ON THE MONITOR . COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736406 ONE STEP COMPLETE ELECTRODES ELECTRODES MKJ BIO-DETEK INCORPORATED 9600-000406-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death