BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1800076 · Received August 11, 2010

    Report

    Report Number
    1720753-2010-02448
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 11, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE BATTERIES WERE REPLACED DURING THE SERVICE CALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600 SYSTEM WAS NOT SAVING OR STORING X-RAY IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1