BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, ONESTEP CPR

    MDR report key: 4902741 · Received July 1, 2015

    Report

    Report Number
    1218058-2015-00032
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    June 11, 2015
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE ELECTRODES WERE RETURNED FOR EVALUATION, THE MALFUNCTION WAS DUPLICATED DURING VISUAL EVALUATION. THE MALFUNCTION WAS ATTRIBUTED TO AN OPEN JUMPER WIRE ON THE ELECTRODE PAD. THIS TYPE OF FAILURE DOES NOT DISABLE THE ELECTRODE FROM DELIVERING THERAPY WHEN ATTACHED TO A DEFIBRILLATOR. THIS IS A MALFUNCTION WHICH ONLY IMPACTS SELF-TEST OF THE ELECTRODE WITH THE DEFIBRILLATOR. THIS TYPE OF MALFUNCTION DOES NOT POSE ANY CLINICAL IMPACT AND DOES NOT MEET OUR GUIDELINES FOR REPORTABILITY. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THESE ATTACHED ELECTRODES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429664 ELECTRODES, ONESTEP CPR ELECTRODES MKJ BIO-DETEK, INC. 8900-0223-01 1015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA