BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINCINNATI SUB ZERO HEATER COOLER

    MDR report key: 11776746 · Received May 4, 2021

    Report

    Report Number
    MW5101169
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    January 25, 2021
    Report Date
    May 3, 2021
    Manufacturer
    CINCINNATI SUB-ZERO / GENTHERM MEDICAL, LLC
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HEATER COOLER CULTURED AS PART OF INVESTIGATION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670845 CINCINNATI SUB ZERO HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC CINCINNATI SUB-ZERO / GENTHERM MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1