BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3042657 · Received April 2, 2013

    Report

    Report Number
    1720753-2013-04491
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLIMATOR LINEAR PLATES WOULD NOT HOLD IN THERE ALIGNED POSITION, THEY CLOSE BY THEMSELVES. THIS ISSUE COULD CAUSE THE SYSTEM TO BECOME UNUSABLE DUE TO THE INABILITY TO VIEW THE LIVE IMAGE. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134801 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1