BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2943115 · Received January 18, 2013

    Report

    Report Number
    9680959-2013-00170
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 18, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION WAS NOT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PROBLEM WITH THE FIRST SCREEN AND THAT THEY WERE UNABLE TO VIEW IMAGES. 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
    28366 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1