BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIVO 785

    MDR report key: 3874555 · Received April 22, 2014

    Report

    Report Number
    9613445-2014-00018
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 22, 2014
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION, THE DVI CONNECTOR WAS EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243180 BRIVO 785 FLUOROSCOPIC X-RAY JAA GE HANGWEI MEDICAL SYSTEMS CO. BRIVO 785

    Patients

    Seq Age Sex Outcome Treatment
    1