BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2191477 · Received July 27, 2011

    Report

    Report Number
    1720753-2011-20457
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 27, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE PRINTER FAILED TO FEED AND PROCESS FILM PROPERLY. THE PRINTER WAS REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY GOT AN ERROR KEY SWITCH IN STANDBY, X-RAY AND LIFT WERE DISABLE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1