BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3161676 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06728
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE COLLIMATOR. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A IRIS POTENTIOMETER ERROR CODE AND WOULD NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243241 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1