BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 4200035 · Received October 21, 2014

    Report

    Report Number
    1720753-2014-08806
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 21, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR ASSEMBLY 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

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A COLLIMATOR POTENTIOMETER ERROR AT BOOT UP AND WOULD NOT TAKE X-RAYS. THIS RESULTED A TOTAL LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN THE DELAY OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670016 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 2800

    Patients

    Seq Age Sex Outcome Treatment
    1