BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3792293 · Received January 10, 2014

    Report

    Report Number
    1720753-2014-00385
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    December 16, 2013
    Report Date
    January 10, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 THE SYSTEM WOULD NOT PRODUCE A FLUOROSCOPIC IMAGE. THIS RENDERED THE SYSTEM UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20644 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1