BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2041464 · Received March 24, 2011

    Report

    Report Number
    1720753-2011-02723
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION, HOWEVER ACCESS WAS DENIED. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORT OF PATIENT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE COLLIMATOR IS FUNCTIONING AUTOMATICALLY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1