BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 4780624 · Received May 15, 2015

    Report

    Report Number
    1720753-2015-02106
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 15, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND THE SOFTWARE WERE INSTALLED 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 IS REPORTED THE SYSTEM WOULD NOT STORE OR RECALL SAVED IMAGES. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318234 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800 P4-0413-L

    Patients

    Seq Age Sex Outcome Treatment
    1