BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1913643 · Received November 12, 2010

    Report

    Report Number
    1720753-2010-04078
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 12, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RELOADED SYSTEM SOFTWARE AND CALIBRATION FILES. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM DISPLAYED A CORRUPT FILES MESSAGE DURING A CASE. NO PT 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) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1