BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1070551 · Received July 1, 2008

    Report

    Report Number
    1220908-2008-01391
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND AFTER EXTENSIVE TESTING THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE DOES NOT INDICATE AN INCREASE IN FREQUENCY.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE INTERMITTENTLY POWERED UP IN MANUAL MODE INAPPROPRIATELY, INSTEAD OF POWERING UP IN AED MODE AS CONFIGURED. COMPLAINANT INDICATED THAT THERE WAS NO 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 BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA