BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1800072 · Received August 11, 2010

    Report

    Report Number
    1720753-2010-02437
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    June 14, 2010
    Report Date
    August 11, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REMOVED AND REPLACED THE HARD DRIVE. RELOADED SOFTWARE AND CONFIG FILES. VERIFIED SYSTEM OPERATION. SAVED TEST PT WITH 18 IMAGES, CYCLED POWER AND RETRIEVED IMAGES WITHOUT ISSUES. VERIFIED SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE RIGHT MONITOR IS LOCKING UP AND THE SYSTEM IS NOT SAVING IMAGES. 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