BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, CPR-D PADZ

    MDR report key: 2883414 · Received November 13, 2012

    Report

    Report Number
    1220908-2012-03055
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K011541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE PROMPTED A "UNIT FAILED" MESSAGE WITH THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODES, CPR-D PADZ ELECTRODES, CPR-D PADZ MKJ ZOLL MEDICAL CORPORATION 8900-0815-36 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA