BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3231117 · Received July 12, 2013

    Report

    Report Number
    1828100-2013-00660
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE COOLER HEATER UNIT WAS NOT MAKING ICE. THE NURSE HAPPENED TO NOTICE THE UNIT DID NOT HAVE ICE IN IT WHEN SHE WALKED INTO THE OPERATING ROOM (O.R.). THERE WAS NO PT OR SURGERY INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322518 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1