BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3811092 · Received March 24, 2014

    Report

    Report Number
    1720753-2014-02656
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR CONTROL PCB ASSEMBLY WAS EVALUATED AND REPLACED. 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 EXHIBITED COMMUNICATION FAILURE ERRORS AND FAILED TO ALLOW FLUOROSCOPIC EXPOSURES. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173384 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1