BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 3111881 · Received May 7, 2013

    Report

    Report Number
    1828100-2013-00428
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE FIELD SERVICE REP (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE COOLER HEATER UNIT WAS LEAKING. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200039 DUAL COOLER/HEATER COOLING & HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP 11160

    Patients

    Seq Age Sex Outcome Treatment
    1