BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1993268 · Received February 7, 2011

    Report

    Report Number
    1720753-2011-01061
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 7, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    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 INTELLIGENT SHUTDOWN DEVICE (ISD) CIRCUIT BOARD. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM WILL 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