BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3915273 · Received May 27, 2014

    Report

    Report Number
    1720753-2014-04501
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    January 16, 2014
    Report Date
    May 27, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELLED THE SERVICE CALL. THE REPORTED PROBLEM WAS RESOLVED BY THE CUSTOMER. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED POTENTIOMETER ERRORS. FURTHER INFORMATION RECEIVED FROM THE FIELD IDENTIFIED THAT THE ERROR RESULTED IN INTERMITTENT SYSTEM FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311404 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1