BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL LLL

    MDR report key: 10275509 · Received July 15, 2020

    Report

    Report Number
    10275509
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 2, 2020
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLANKETROL III MACHINE INTERMITTENTLY TURNED OFF AND READ 'LOW WATER' DESPITE BEING FULL OF STERILE WATER. PATIENT'S VITALS REMAIN UNCHANGED AND PLACED ON NEW COOLING BLANKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740787 BLANKETROL LLL SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 233

    Patients

    Seq Age Sex Outcome Treatment
    1