BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1872090 · Received October 14, 2010

    Report

    Report Number
    9680959-2010-00401
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND HAS ORDERED PARTS FOR REPLACEMENT. PARTS HAVE NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE COLLIMATOR WILL NOT CHANGE SIZE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1