BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MR. FROSTY

    MDR report key: 18086510 · Received November 6, 2023

    Report

    Report Number
    MW5147868
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    October 23, 2023
    Report Date
    November 1, 2023
    Manufacturer
    SPECTRUM MEDICAL LTD.
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARDIOPULMONARY BYPASS HEATER/COOLER DEVICE "FAILURE" TO REHEAT PATIENT. PATIENT TEMPERATURE 31.8C WHEN DEVICE FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688751 MR. FROSTY CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SPECTRUM MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention| O