BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINCINNATI SUB ZERO HEATER COOLER

    MDR report key: 11776729 · Received May 4, 2021

    Report

    Report Number
    MW5101168
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    October 14, 2020
    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 HEATER AND COOLER CULTURING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670844 CINCINNATI SUB ZERO HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC CINCINNATI SUB ZERO / GENTHERM MEDICAL, LLC .

    Patients

    Seq Age Sex Outcome Treatment
    1