BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3960826 · Received June 27, 2014

    Report

    Report Number
    1720753-2014-05545
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 27, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CPU COIN BATTERY WAS EVALUATED AND REPLACED. THE BIOS SETTINGS WERE ALSO RESET DURING THE SERVICE EVENT. 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 THERE WAS A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR RESULTED IN THE SYSTEM FAILING TO BOOT TO A USABLE STATE AND RESULTED IN A NON-RECOVERABLE LOSS OF SYSTEM FUNCTIONALITY. THERE IS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375871 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 8800

    Patients

    Seq Age Sex Outcome Treatment
    1