BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE CENTRAL STATION

    MDR report key: 11884520 · Received May 26, 2021

    Report

    Report Number
    11884520
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 24, 2021
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CENTRAL PATIENT MONITORING STATION LOST POWER AND THE SCREEN WENT BLANK. CLINICAL STAFF ATTEMPTED TO UNPLUG AND PLUG THE POWER CORD AND THE MACHINE MADE A POPPING NOISE. SPARKS WERE THEN NOTED TO BE COMING FROM THE SIDE OF THE MACHINE AND SCREEN REMAINED BLANK. SMOKE WAS ALSO NOTED TO BE COMING OUT OF THE SIDE OF THE MACHINE. MACHINE UNPLUGGED, BIOMEDICAL ENGINEERING WAS NOTIFIED AND REMOVED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784519 CARESCAPE CENTRAL STATION COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. V2 INTEGRATED MAI 700

    Patients

    Seq Age Sex Outcome Treatment
    1