BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2934192 · Received January 3, 2013

    Report

    Report Number
    1720753-2013-00111
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 3, 2013
    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 SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE C-ARM BATTERIES WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE OPERATED AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES BECAME GRAINY AND THEY TERMINATED THE USE OF THE SYSTEM. THE SYSTEM THEN DISPLAYED A PRECHARGE ERROR MESSAGE. THE CASE WAS COMPLETED WITH ANOTHER UNIT. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3884 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1