BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1070545 · Received July 1, 2008

    Report

    Report Number
    1220908-2008-01362
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVAL, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING SET-UP OF THE DEVICE PRIOR BEING USED ON A PT, THE DEVICE SELF-CHARGED ENERGY INAPPROPRIATELY. 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 BI-PHASIC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA