BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4214035 · Received October 24, 2014

    Report

    Report Number
    1720753-2014-08902
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED, FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM TRIPS THE CIRCUIT BREAKER ADJACENT TO THE POWER CORD EVERY TIME IT IS PLUGGED IN. THE FE CONFIRMED THE SYSTEM WOULD NOT BOOT. THIS COULD CAUSE 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
    678931 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1