BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2954161 · Received July 12, 2007

    Report

    Report Number
    1720753-2007-08911
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 19, 2007
    Report Date
    July 12, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THAT NO SERVICE REQUESTED. A FOLLOW-UP REPORT WILL BE FILED FOR ANY ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9900 SYSTEM HAD UNEXPECTED COLLIMATOR CLOSE DOWN AND SYSTEM HAD TO BE REBOOTED TWICE. NO PT INJURY REPORTED AND CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK