BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1040803 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21395
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL BIO-MED RE-CYCLED THE POWER AND SYSTEM WAS OPERATIONAL UPON ARRIVAL. THE GE SERVICE REP PERFORMED SYSTEM-OPERATIONAL CHECKS TO INCLUDE IMAGE RETRIEVAL FUNCTIONS, AND FLUORO CAPABILITIES WITH NO PROBLEMS NOTED. SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT FLUORO AFTER A POWER SURGE IN THE FACILITY. SYSTEM WAS SHUTDOWN, BUT THE TABLE STAYED ON. NO ATTEMPT TO RE-CYCLE POWER WAS ATTEMPTED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1