BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2243629 · Received August 24, 2011

    Report

    Report Number
    1720753-2011-21338
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SVC REP REPLACED THE HIGH VOLTAGE CABLE ASSEMBLY, REASSEMBLED THE OPS AND REPLACED THE HANDSWITCH. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS LOST ABILITY TO PERFORM FLUOROSCOPY WHEN THE C-ARM WAS MOVED FROM A/P TO LATERAL POSITION. THIS HAPPENED DURING A PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1