BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER /HEATER

    MDR report key: 2180817 · Received July 1, 2011

    Report

    Report Number
    1828100-2011-01853
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 8, 2011
    Report Date
    July 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE FIELD SERVICE REP REPORTED THAT THE DUAL COOLER HEATER LEAKED AT THE MOTOR HOUSING AND THERMOMETER. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL COOLER /HEATER COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1