BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 9267721 · Received November 1, 2019

    Report

    Report Number
    1220908-2019-03342
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Report Date
    October 11, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRO
    UDI-DI
    00847946003210
    PMA / PMN Number
    K972241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS CONTACTED FOR RETURN OF THE SUSPECT PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO ZOLL FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "PACER FAULT 85," "PACER DISABLED," AND "DEFIB DISABLED" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060499 M SERIES DEFIBRILLATOR/PACEMAKER DRO ZOLL MEDICAL CORPORATION MSERIES NA 00847946003210

    Patients

    Seq Age Sex Outcome Treatment
    1