BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3843384 · Received March 14, 2014

    Report

    Report Number
    1720753-2014-02319
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 14, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM TURNED OFF, RESULTING IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153182 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1