BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3060365 · Received April 11, 2013

    Report

    Report Number
    1720753-2013-04866
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CPU AND UNIVERSAL NODE WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN X-RAY DISABLED ERROR MESSAGE AT BOOT UP WHICH PREVENTED THE SYSTEM FROM COMPLETING BOOT UP. SEVERAL REBOOTS WOULD NOT CLEAR THE ERROR. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154615 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1