BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1844778 · Received September 23, 2010

    Report

    Report Number
    1720753-2010-03192
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    July 28, 2010
    Report Date
    September 23, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RELOADED THE SYSTEM SOFTWARE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM DISPLAYED A FILE CORRUPTION ERROR AND WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    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