BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4090012 · Received August 18, 2014

    Report

    Report Number
    1720753-2014-07060
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 18, 2014
    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 SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE CIRCUIT BREAKER 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 THERE WAS NO POWER TO THE SYSTEM AND IT WOULD NOT TURN ON. THIS RESULTED A TOTAL LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN THE DELAY OR CANCELLATION 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
    496404 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1