BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1040735 · Received May 9, 2008

    Report

    Report Number
    9617766-2008-01120
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 9, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS HAVING PROBLEMS LOWERING C-ARM AND COLLIMATOR ISSUES. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1