BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2896074 · Received December 10, 2012

    Report

    Report Number
    1720753-2012-10291
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 10, 2012
    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 INTERCONNECT CABLE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A "GENERATOR ERROR". THIS ERROR IS LIKELY TO RESULT IN AN UN-COMMANDED LOSS OF SYSTEM FUNCTIONALITY AND REQUIRE A SYSTEM REBOOT. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1