BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 1961234 · Received January 11, 2011

    Report

    Report Number
    9680959-2011-00049
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    October 13, 2008
    Report Date
    January 11, 2011
    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 REP DID NOT REPORT ON EVALUATION OR REPAIR OF THIS SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 7600 SYSTEM WOULD OCCASIONALLY NOT SWITCH ON. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7600

    Patients

    Seq Age Sex Outcome Treatment
    1