BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1881763 · Received October 11, 2010

    Report

    Report Number
    1720753-2010-03486
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 11, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND DETERMINED THE COLLIMATOR NEEDED TO BE REPLACED. CUSTOMER HAS DECLINED TO REPLACE THE COLLIMATOR AND HAS RETURNED THE SYSTEM TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE SYSTEM DISPLAYED A COLLIMATOR IRIS POT ERROR AND SHUT DOWN DURING A PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1