BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, ONESTEP COMPLETE

    MDR report key: 4743169 · Received April 27, 2015

    Report

    Report Number
    1218058-2015-00012
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Report Date
    April 7, 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 AND 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 DEVICE DISPLAYED A "CHECK PADS" MESSAGE WITH THESE ASSOCIATED ELECTRODE PADS ATTACHED. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275117 ELECTRODES, ONESTEP COMPLETE ELECTRODE MKJ BIO-DETEK, INC. 8900-0224-01 4014A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA