BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4203088 · Received September 18, 2014

    Report

    Report Number
    1720753-2014-07972
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 18, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE FFB AND GIB PCBS WERE EVALUATED AND REPLACED. THE CONFIGURATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR WOULD NOT TURN ON (NO-BOOT). THE FE FOUND COMMUNICATION FAILED ERROR MESSAGES IN THE ERROR LOGS. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578789 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1