BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2973862 · Received February 19, 2013

    Report

    Report Number
    1720753-2013-01934
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 19, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN IRIS POTENTIOMETER ERROR MESSAGE. THIS ERROR MESSAGE ON THE 9600 SYSTEM PREVENTS THE X-RAY FUNCTION FROM WORKING AND IT WILL SHUT THE SYSTEM DOWN. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72449 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1