BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3902267 · Received February 24, 2014

    Report

    Report Number
    9680959-2014-00266
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE SYSTEM FAILED TO ALLOW THE GENERATION OF A FLUOROSCOPIC IMAGE. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113513 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1