BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1014011 · Received March 13, 2008

    Report

    Report Number
    1220908-2008-00557
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED MALFUNCTION WAS OBSERVED DURING INITIAL TESTING. HOWEVER, AFTER THE DEVICE WAS DISASSEMBLED TO ISOLATE ROOT CAUSE, THE REPORTED PROBLEM COULD NO LONGER BE DUPLICATED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING AND THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED. THE HV MODULE WAS REPLACED AS A PRECAUTION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA