BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2021875 · Received February 25, 2011

    Report

    Report Number
    1720753-2011-01687
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 25, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP PERFORMED AN ON SITE INVESTIGATION. THE XRAY TUBE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM REVERTS TO THE PREPARATION STAGE AFTER A FEW MINUTES OF FLUOROSCOPY XRAY. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1