BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1865012 · Received October 6, 2010

    Report

    Report Number
    1720753-2010-03412
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 6, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYS SHUT DOWN AND WOULD NOT REBOOT. SYS OPERATES AS INTENDED.

    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