BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR 8000M

    MDR report key: 395724 · Received May 21, 2002

    Report

    Report Number
    MW1025080
    Event Type
    Malfunction
    Date Received
    May 21, 2002
    Date of Event
    February 7, 2002
    Report Date
    May 10, 2002
    Manufacturer
    G.E. MARQUETTE MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHEN MONITOR PUT IN "3 MINUTES ALARM SUSPEND", IT WOULD STAY THERE FOR AS LONG AS 20 MINUTES BEFORE IT WOULD RESET ITSELF AND COUNT DOWN AGAIN. THIS HAS HAPPENED SEVERAL TIMES. G.E. ACKNOWLEDGED THE PROBLEM AND IS ADDRESSED IN THE NEXT SOFTWARE VERSION. (3B).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLAR 8000M PHYSIOLOGIC MONITOR MHX G.E. MARQUETTE MEDICAL SYSTEMS SOLAR 8000M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *