BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3960255 · Received June 24, 2014

    Report

    Report Number
    1720753-2014-05378
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    September 10, 2013
    Report Date
    June 23, 2014
    Manufacturer
    GE OCE MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DRIVE WAS EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE SYSTEM BOOTED TO A HARD DRIVE ERROR (NO BOOT). THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367383 9900 FLUOROSCOPIC X-RAY JAA GE OCE MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1