BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR 8000

    MDR report key: 13994561 · Received April 4, 2022

    Report

    Report Number
    13994561
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 22, 2022
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BEDSIDE GE MONITOR FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77186 SOLAR 8000 DETECTOR AND ALARM, ARRHYTHMIA DSI GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. SOLAR 8000

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA Male