BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL III

    MDR report key: 6906758 · Received October 2, 2017

    Report

    Report Number
    6906758
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    June 30, 2017
    Report Date
    September 8, 2017
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE NOTED WATER ALL OVER THE FLOOR, DRIPPING FROM PATIENT BED. UPON INVESTIGATION, COOLING BLANKET FOUND TO BE LEAKING. PATIENT MONITORED WITH NO ADVERSE PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687407 BLANKETROL III SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR