BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2844322 · Received November 8, 2012

    Report

    Report Number
    1720753-2012-09200
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 8, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE COLLIMATOR WAS IDENTIFIED AS HAVING SHIFTED POSITION DUE TO A MISSING SCREW. THE SCREW WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A COLLIMATOR IRIS POTENTIOMETER ERROR MESSAGE DURING PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1