BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 465276 · Received June 6, 2003

    Report

    Report Number
    1220908-2003-00781
    Event Type
    Malfunction
    Date Received
    June 6, 2003
    Report Date
    May 9, 2003
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYS A RED "X" AND INAPPROPRIATELY SHUTS DOWN BEORE A TEST OK IS HEARD. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORP AED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other