BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4774528 · Received May 13, 2015

    Report

    Report Number
    1720753-2015-02061
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 29, 2015
    Report Date
    May 13, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS 82-2194-RC
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE 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 MONITOR BLACKED OUT DURING A CASE. THE FIELD ENGINEER NOTED THAT THE WORKSTATION LOCKED UP AND THE SYSTEM WOULD NOT BOOT UP. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313396 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 82-2194-RC 9900 ES-1994

    Patients

    Seq Age Sex Outcome Treatment
    1