BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2850508 · Received November 27, 2012

    Report

    Report Number
    9680959-2012-01601
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 27, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND PLACED THE FRAME GRABBER BOARD ON ORDER, BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY A FLUOROSCOPY IMAGE, THUS MAKING THE SYSTEM UNUSABLE. 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
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1