BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD STELLANT D INJECTOR SYSTEM

    MDR report key: 3695629 · Received March 19, 2014

    Report

    Report Number
    MW5035127
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MEDRAD STELLANT D INJECTOR SYSTEM. COMPANY REFUSES TO PROVIDE (EVEN IF WE PURCHASE) THE SOFTWARE TO CALIBRATE THE HEAD SENSOR. THIS IN DIRECT VIOLATION OF ALLOWING THE END USER THE ABILITY TO SERVICE THE UNIT. THEY WILL PROVIDE SOFTWARE IF YOU GO TO THEIR CLASS; BUY A LICENSE PARTNERSHIP AGREEMENT (SERVICE CONTRACT) WITH THEM FOR EACH UNIT. BAYER HEALTHCARE MAKES THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162056 MEDRAD STELLANT D INJECTOR SYSTEM INJECTOR SYSTEM DXT MEDRAD STELLANT D INJECTOR

    Patients

    Seq Age Sex Outcome Treatment
    1