BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2935377 · Received January 28, 2013

    Report

    Report Number
    1720753-2013-01137
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 28, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RESEATED CIRCUIT BOARDS, CABLES, AND CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLIMATOR IRIS AND COLLIMATOR BLADES WERE CLOSED ALL THE WAY AND NOT FUNCTIONING. THIS ISSUE COULD PREVENT THE LIVE IMAGE FROM BEING VIEWED, THEREBY MAKING THE SYSTEM UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38023 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1