BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 401512 · Received June 20, 2002

    Report

    Report Number
    1220908-2002-00938
    Event Type
    Malfunction
    Date Received
    June 20, 2002
    Date of Event
    May 26, 2002
    Report Date
    May 30, 2002
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT AGGED THAT THE CLINICIANS WERE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE AND GENDER UNKNOWN), BUT THE DEVICE DISCHARGE BUTTON BECAME "STUCK" INSIDE THE UNIT'S HOUSING. THE CHARGED ENERGY WAS INTERNALLY DUMPED, AND THE CLINICIANS AGAIN CHARGED THE DEVICE AND SUCCESSFULLY ADMINISTERED THE SHOCK TO THE PATIENT. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT ON THE PATIENT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other