BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4801868 · Received May 26, 2015

    Report

    Report Number
    1720753-2015-02224
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    May 11, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE SOFTWARE WAS INSTALLED DURING THE SVC CALL. THE SYS 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 WOULD NOT BOOT UP. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341033 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1