BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3113065 · Received May 9, 2013

    Report

    Report Number
    1720753-2013-05881
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 9, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SCL)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE SINGLE BOARD COMPUTER AND REFORMATTED THE HARD DRIVE AND RELOADED SOFTWARE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT COMPLETED BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204716 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SCL) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1