BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3182467 · Received June 14, 2013

    Report

    Report Number
    1720753-2013-07144
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS REPLACED DURING THE SVC CALL. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYS HAD A COLLIMATOR IRIS TOO LARGE ERROR, AND THAT THE COLLIMATOR IRIS WAS CLOSED DOWN. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272341 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1