BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2022272 · Received February 28, 2011

    Report

    Report Number
    1720753-2011-01733
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 28, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP PERFORMED AN ON SITE INVESTIGATION. THE SOFTWARE WAS RELOADED. THE FLUORO FUNCTION BOARD, THE GENERATOR INTERFACE BOARD AND THE HIGH VELOCITY BOARD WERE RESEATED. THE PS1 VOLTAGE WAS ADJUSTED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYS FAILED TO BOOT UP. NO REPORT OF PT INJURY.

    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