BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 4844552 · Received June 11, 2015

    Report

    Report Number
    1720753-2015-02412
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 11, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DISK DRIVE WAS EVALUATED AND REFORMATTED. VERSION 10 OF SYSTEM SOFTWARE AND ASSOCIATED CALIBRATIONS WERE RELOADED DURING THE SERVICE EVENT. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTER-MIXED PATIENT IMAGE DATA. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381040 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800 86-1425

    Patients

    Seq Age Sex Outcome Treatment
    1