BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1961147 · Received January 11, 2011

    Report

    Report Number
    1720753-2011-00149
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    September 27, 2007
    Report Date
    January 11, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    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 AND REPAIRED THE SYSTEM. HOWEVER, NO DETAILS ARE AVAILABLE. NO REPORTS OF PT OR STAFF INJURY WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO PRODUCE X-RAYS DURING PULSE AND CINE MODE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1