BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3060881 · Received April 10, 2013

    Report

    Report Number
    1828100-2013-00339
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 20, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD TAGGED THE UNIT FOR THE FIELD SERVICE REPRESENTATIVE (FSR) TO REPAIR, AND THE FSR FOUND UNIT WHEN HE WENT OUT FOR A PREVENTATIVE MAINTENANCE (PM). THIS COMPLAINT IS RELATED TO MDR # 1828100-2013-00360 AND 1828100-2013-00362.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COOLER HEATER UNIT WAS LEAKING AT VALVE 3. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149920 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1