BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3013156 · Received March 1, 2013

    Report

    Report Number
    1720753-2013-03243
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 1, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD INTERMITTENTLY NOT BOOT UP. 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
    90344 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900

    Patients

    Seq Age Sex Outcome Treatment
    1