BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE CENTRAL STATION

    MDR report key: 11663570 · Received April 14, 2021

    Report

    Report Number
    11663570
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 7, 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

    THE CENTRAL STATION WAS REPORTED TO HAVE GONE DARK AND BIOMED WAS CALLED. A BIOMEDICAL ENGINEERING TECHNICIAN TURNED THE CENTRAL OFF AND BACK ON AGAIN. UPON TURNING THE DEVICE BACK ON THERE WAS A POPPING NOISE AND THE DEVICE SMOKED. THE DEVICE WAS UNPLUGGED AND REMOVED. IT WAS DISCOVERED THAT THE POWER SUPPLY ASSEMBLY SMELLED OF SMOKE, HAD SCORCH MARKS, AND A DEFORMED COMPONENT. THE FUSES WERE ALSO SWAPPED ALTHOUGH NEITHER FUSE FAILED DURING THE POWER SUPPLY ASSEMBLY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562985 CARESCAPE CENTRAL STATION COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. V2 INTEGRATED MAI 700

    Patients

    Seq Age Sex Outcome Treatment
    1