BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 2030819 · Received March 4, 2011

    Report

    Report Number
    1828100-2011-00611
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 4, 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 PREVENTATIVE MAINTENANCE OF THE DEVICE, THE FIELD SERVICE REPRESENTATIVE REPORTED THAT AS A RESULT OF VALVE 1, THE DEVICE TOOK TOO LONG TO HEAT AND THE WATER WAS "TRICKLING". SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PT 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