BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2100274 · Received May 16, 2011

    Report

    Report Number
    9617766-2011-01059
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 16, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. TECHNICAL SUPPORT WAS PROVIDED TO THE CUSTOMER TO REPLACE THE CABLE TO THE C-ARM AND IN THE INTERIM TO RUN THE CASE(S) WITHOUT USING THE COLLIMATOR IRIS. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADDITIONAL SERVICE INFO WAS PROVIDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM'S COLLIMATOR IRIS WAS OUT OF RANGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1