BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3231076 · Received July 12, 2013

    Report

    Report Number
    1720753-2013-08063
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 12, 2013
    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 POWER PLUG SCREWS WERE RETIGHTENED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN IN THE MIDDLE OF A CASE AND THEN WOULD NOT BOOT BACK UP. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321955 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1