BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3823034 · Received February 5, 2014

    Report

    Report Number
    1720753-2014-01172
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    December 9, 2013
    Report Date
    February 5, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CPU BATTERY NEEDS TO BE REPLACED. THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MDA MEMORY PREVENTED THE SYSTEM FROM BOOTING UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75949 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1