BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2043493 · Received March 28, 2011

    Report

    Report Number
    1720753-2011-02935
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    April 22, 2010
    Report Date
    March 28, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE GENERATOR INTERFACE BOARD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY WOULD NOT PRODUCE X-RAYS DURING PROCEDURES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1