BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1872294 · Received October 12, 2010

    Report

    Report Number
    1720753-2010-03516
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 12, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THE SYSTEM STILL HAD AN ODOR OF A BURNED COMPONENT, BUT WAS UNABLE TO FIND ANY COMPROMISED ITEM. SYSTEM BOOTED UP AND WORKED AS INTENDED. PERFORMED SEVERAL BOOT-UPS AND SEVERAL FLUORO SHOTS, AT NORMAL AND AT HIGH LEVEL FLUORO. SYSTEM APPEARS TO BE WORKING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WOULD NOT BOOT AND THERE WAS A BURNING SMELL COMING FROM THE WORKSTATION. NO PATIENT 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