BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2961605 · Received February 11, 2013

    Report

    Report Number
    1720753-2013-01629
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE RTOS SINGLE BOARD COMPUTER. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT BOOT UP. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60207 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1