BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1600 SEMI AUTOMATIC DEFIBRILLATOR

    MDR report key: 350036 · Received August 29, 2001

    Report

    Report Number
    1220908-2001-01179
    Event Type
    Malfunction
    Date Received
    August 29, 2001
    Report Date
    July 30, 2001
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK OF THE DEVICE BY A CLINICIAN, THE UNIT DISPLAYED "STATUS 66", "STATUS 93", "STATUS 110" MESSAGES, AND A "CANNOT DUMP" MESSAGE. THE COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39195 1600 SEMI AUTOMATIC DEFIBRILLATOR DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION 1600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other