BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1030509 · Received April 16, 2008

    Report

    Report Number
    1220908-2008-00764
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 23, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP EVALUATED THE DEVICE AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT THE DEVICE FAILED TO DISCHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK