BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2960874 · Received January 30, 2013

    Report

    Report Number
    1720753-2013-01275
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SUBTRACTION FUNCTION WAS NOT WORKING, RESULTING IN A LOSS OF CRITICAL VASCULAR FEATURES. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41448 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1