BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 7638687 · Received June 26, 2018

    Report

    Report Number
    1220908-2018-01708
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Report Date
    June 5, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K011865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS CONTACTED FOR RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO ZOLL FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE = DRO. 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 BIOMED TESTING, THE DEVICE DISPLAYED "SYSTEM FAULT 36", "DEFIB FAULT 72" AND "PACER FAULT 116" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482415 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION MSERIES CCT NA

    Patients

    Seq Age Sex Outcome Treatment
    1