BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4780664 · Received May 15, 2015

    Report

    Report Number
    1720753-2015-02093
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 15, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED CONNECTORS WERE RESEATED AND THE CINE DRIVE 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

    IT WAS REPORTED THE SYSTEM DISPLAYED A CINE DISC ERROR ON BOOT UP AND HAD A LOSS OF CINE FUNCTION. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318742 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900

    Patients

    Seq Age Sex Outcome Treatment
    1