BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1885081 · Received October 20, 2010

    Report

    Report Number
    1720753-2010-03669
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 20, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE FAST SCAN CONVERTER BOARD. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SYSTEM WOULD NOT BOOT UP, AND NO DISPLAY ON EITHER MONITOR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1