BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 1961138 · Received January 11, 2011

    Report

    Report Number
    1828100-2010-02856
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 11, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THE INTERNAL RUBBER HOSES WERE DETERIORATING. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1