BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 1715598 · Received October 5, 2009

    Report

    Report Number
    1720753-2009-07193
    Event Type
    Malfunction
    Date Received
    October 5, 2009
    Date of Event
    June 26, 2009
    Report Date
    September 28, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE CDA WAS ADJUSTED TO 2.54 MM. THE SYSTEM WAS REPAIRED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM HAD A IQC FAILURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1