BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

    MDR report key: 7925798 · Received October 2, 2018

    Report

    Report Number
    7925798
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    February 13, 2018
    Report Date
    September 21, 2018
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    C-ARM WAS BROUGHT INTO OPERATING ROOM PRIOR TO START OF PROCEDURE AND TURNED ON. UPON TURNING ON THE C-ARM, THE SCREEN SAID "VOLTAGE ERROR, RESTART SYSTEM". C-ARM WAS RESTARTED 4 TIMES AND BIO-MED WAS CALLED. BIO-MED CAME TO THE OPERATING ROOM AND AGAIN TRIED TO RESTART THE MACHINE AND BYPASS THE ERROR CODE. BIO-MED WAS NOT ABLE TO FIX THE MALFUNCTION AND PROCEEDED TO CALL THE HELP NUMBER ON THE BACK OF THE MACHINE. INITIALLY, ANOTHER C-ARM WAS NOT AVAILABLE. ONCE ANOTHER C-ARM BECAME AVAILABLE, THE C-ARM THAT WAS NOT WORKING WAS REMOVED FROM THE ROOM AND A NEW C-ARM WAS BROUGHT INTO THE ROOM TO START THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766050 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA GE OEC MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 32850 DA