BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 2150821 · Received June 21, 2011

    Report

    Report Number
    1720753-2011-08337
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE TABLE SENSOR BOARD AND ADJUSTED THE POWER SUPPLY. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY THE ERROR CODE 425. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2600

    Patients

    Seq Age Sex Outcome Treatment
    1