BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2884926 · Received December 4, 2012

    Report

    Report Number
    1720753-2012-10065
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 4, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE COLLIMATOR AND COLLIMATOR COVER. THE SYSTEM OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A COLLIMATOR IRIS POT ERROR MESSAGE AND A COLLIMATOR IRIS TOO LARGE DURING A PROCEDURE. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1