BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3162120 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06682
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RESEATED CIRCUIT BOARDS, CABLES, AND CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT SATURATION FAULT ERROR MESSAGE. THIS ERROR PREVENTS THE SYSTEM FROM OPERATING. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242717 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9600

    Patients

    Seq Age Sex Outcome Treatment
    1