BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2062917 · Received March 21, 2011

    Report

    Report Number
    1720753-2011-02554
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP CONDUCTED AN ONSITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGE ON THE LEFT MONITOR WAS DARK ON THE 9800 SYSTEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1