BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1992931 · Received February 5, 2011

    Report

    Report Number
    9680959-2011-00273
    Event Type
    Malfunction
    Date Received
    February 5, 2011
    Date of Event
    July 13, 2009
    Report Date
    February 5, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE MAIN CONTROL BOARD WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM'S COLLIMATOR FAILED TO OPERATE PROPERLY. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC XRAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1