BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1881781 · Received October 11, 2010

    Report

    Report Number
    1720753-2010-03489
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 11, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE ARO. A GE REP EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. RESEATED FUSES ON THE MOTHERBOARD AS A PRECAUTIONARY MEASURE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING A CASE, THE USER PUSHED THE FLUORO BUTTON, AND WHEN THEY RELEASED THE BUTTON, THE UNIT CONTINUED TO FLUORO. SYSTEM HAD TO BE REBOOTED TO SHUT OFF X-RAY ALARM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1