BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4134052 · Received September 26, 2014

    Report

    Report Number
    1720753-2014-08173
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 25, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS(SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED 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 WAS MAKING X-RAY WITHOUT COMMAND. THE FSE EXPLAINED THE SYSTEM LOCKED UP AND THERE WAS NO UNCOMMANDED X-RAY. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603089 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS(SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1