BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR 8000M

    MDR report key: 7009375 · Received November 8, 2017

    Report

    Report Number
    7009375
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    July 20, 2017
    Report Date
    September 29, 2017
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SCREEN ON BEDSIDE MONITOR IN ROOM WAS NOT WORKING. BIOMED WAS CALLED AND "PIZZA BOX" WAS BAD. THIS IS AT LEAST THE THIRD ONE IN THE LAST SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787933 SOLAR 8000M MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. SOLAR 8000M

    Patients

    Seq Age Sex Outcome Treatment
    1