BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1060502 · Received June 11, 2008

    Report

    Report Number
    1220908-2008-01208
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ZOLL. THE CUSTOMER REMOVED AND RETURNED THE SUSPECT HV MODULE FOR EVALUATION; HOWEVER, TESTING OF THE HV MODULE WAS NOT ABLE TO DUPLICATE THE MALFUNCTION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE DEVICE DISPLAYED A "PACER FAULT 117" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT 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