BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2102165 · Received May 19, 2011

    Report

    Report Number
    1720753-2011-07469
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 19, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED. THE CANDLESTICKS WERE DRY WITH SOME CARBON RESIDUE INDICATIVE OF ARCING. THEY WERE CLEANED AND RE-GREASED. THE MANUFACTURER'S REPRESENTATIVE RECOMMENDED THAT THE CUSTOMER REMOVE THE BACK TO THE UNIT AS IT DOES NOT HAVE A FAN AND IS IN CONTINUOUS USE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM CONTINUED TO PERFORM FLUOROSCOPY UNCOMMANDED, AND THERE WAS AN ARCHING NOISE FROM THE TUBE FOLLOWING WHICH THE C-ARM WOULD LOCK UP. ALSO THE SYSTEM INTERMITTENTLY BOOTED UP WITH A GRAY SCREEN. 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