BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 8800

    MDR report key: 1021700 · Received March 19, 2008

    Report

    Report Number
    9617766-2008-00133
    Event Type
    Malfunction
    Date Received
    March 19, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 17, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CANCELLED CALL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE COLLIMATOR IS OPEN TOO WIDE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. 8800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1