BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2772161 · Received October 2, 2012

    Report

    Report Number
    1720753-2012-07884
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 2, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE SYSTEM INTERFACE BOARD, THE KV CONTROLLER BOARD, AND THE AEC CABLE, AND RELOADED SOFTWARE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT ALLOW FLUOROSCOPIC X-RAY EXPOSURES. THERE IS NO PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1