BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL III

    MDR report key: 7137723 · Received December 21, 2017

    Report

    Report Number
    7137723
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 12, 2017
    Report Date
    December 12, 2017
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CINCINNATI SUB-ZERO BLANKETROL III SYSTEM WAS BEING USED TO COOL BODY TEMPERATURE TO 33.5. THE BODY TEMPERATURE NEVER GOT BELOW 34.0. THE NURSE NOTICED THAT THERE WAS NO WATER IN THE COOLING BLANKET. THE CINCINNATI SUB-ZERO BLANKETROL III SYSTEM WAS SWITCHED OUT. NO UNTOWARD PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917984 BLANKETROL III SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR