BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 1178346 · Received September 30, 2008

    Report

    Report Number
    1720753-2008-22615
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP CONDUCTED AN ON SITE EVALUATION. THE REP ADJUSTED THE HLV FLUOPRO DOSE TO 17.1R/MIN IAW INSTRUCTIONS. SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PHYSICIST DESCREPANCY. HLV EXCEDDING DOSE LIMITS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1