BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 2934666 · Received January 4, 2013

    Report

    Report Number
    9680959-2013-00045
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THE MONOBLOCK GENERATOR NEEDED TO BE REPLACED. THE SYSTEM IS AT END OF LIFE, AND PARTS ARE NOT AVAILABLE. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE SYSTEM COULD NOT PRODUCE X-RAY IMAGES. THIS ISSUE WOULD PREVENT THE LIVE IMAGE FROM BEING VIEWED, THEREBY 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
    5760 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7600

    Patients

    Seq Age Sex Outcome Treatment
    1