BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3874578 · Received April 22, 2014

    Report

    Report Number
    1720753-2014-03531
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    June 20, 2013
    Report Date
    April 22, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. A SYSTEM SUPPLY WAS EVALUATED AND REPLACED TO CORRECT THE ALLEGED ISSUE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNKNOWN ERRORS. FURTHER INFORMATION WAS RECEIVED FROM THE FSE INDICATING THAT THE MAINFRAME PORTION OF THE SYSTEM FAILED TO BOOT TO A USABLE STATE. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242923 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1