BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 1861206 · Received October 4, 2010

    Report

    Report Number
    1720753-2010-03363
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    June 17, 2010
    Report Date
    October 4, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE X-RAY CONTROLLER BOARD. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WILL LOCK UP DURING EXTENDED X-RAYS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1