BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4801848 · Received May 26, 2015

    Report

    Report Number
    1720753-2015-02226
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 26, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE FUSES, BOARDS, AND CONNECTORS WERE RESEATED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM SHOWS THE CINE DISC IS NOT RECOGNIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339887 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900 ES-1678

    Patients

    Seq Age Sex Outcome Treatment
    1