BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2191942 · Received July 22, 2011

    Report

    Report Number
    1720753-2011-20325
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 22, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE POWER SUPPLY, FLUORO FUNCTIONS BOARD, GENERATOR INTERFACE BOARD AND BACK PLANE BOARD WERE REPLACED. THE SYSTEM WAS TESTED AND FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE X-RAYS STAY ON AFTER THE X-RAY SWITCH WAS RELEASED. 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