BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3792011 · Received January 14, 2014

    Report

    Report Number
    1720753-2014-00461
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 14, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM SOFTWARE WAS EVALUATED AND RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM INTERMITTENTLY WOULD NOT BOOT UP. THIS ISSUE WILL RESULT IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY, HIC COULD RESULT IN PROCEDURAL DELAYS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36066 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1