BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP PEDIATRIC RESUSCITATION ELECTRODE

    MDR report key: 4737595 · Received April 24, 2015

    Report

    Report Number
    1218058-2015-00008
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Report Date
    April 6, 2015
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS REC'D THE PROD AN WILL BE PROVIDING A F/U REPORT WHEN OUT INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ELECTRODES CAUSED THE ASSOCIATED DEFIBRILLATOR TO DISPLAY A "CHECK PADS" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271679 ONESTEP PEDIATRIC RESUSCITATION ELECTRODE ELECTRODE MKJ BIO-DETEK, INC. 8900-0215 1114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA