BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1812060 · Received August 17, 2010

    Report

    Report Number
    1720753-2010-02552
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 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

    POSSIBLE ARO. A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RECALIBRATED THE MA OUTPUT. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE SYSTEM DISPLAYED A HIGH MA ERROR. NO PATIENT 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