BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1880011 · Received October 13, 2010

    Report

    Report Number
    1720753-2010-03534
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    July 30, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED BY PHONE CALL THAT THE SYSTEM IS WORKING, AND CUSTOMER IS MONITORING THE SYSTEM. NO GE SERVICE WAS PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM DISPLAYED AN X-RAY SWITCH ERROR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC)

    Patients

    Seq Age Sex Outcome Treatment
    1