BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL LLL

    MDR report key: 11811839 · Received May 12, 2021

    Report

    Report Number
    11811839
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 22, 2021
    Report Date
    April 30, 2021
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CALLED TO BEDSIDE BECAUSE PATIENT WAS NOT REACHING GOAL TEMP OF 33.5°C AND THE WATER INDICATOR WHEEL, FROM THE BLANKETROL III SYSTEM, WAS NO LONGER SPINNING. HEALTH CARE PROVIDERS CHECKED THE MACHINE TO MAKE SURE THERE WERE NO KINKS IN THE HOSES OR BLANKET THAT WOULD CUT OFF THE FLOW. WENT THROUGH ALL TROUBLE SHOOTING STEPS AND THEN SWITCHED OUT THE MACHINE. THE SECOND MACHINE THEN READ "SNAP DISC", AND WE HAD TO GO TO THE PEDIATRIC INTENSIVE CARE UNIT TO FIND A THIRD MACHINE. BUT, ENCOUNTERED THE SAME ISSUE WITH THE THIRD MACHINE. CINCINNATI SUB-ZERO PRODUCTS, INC. 24HR SUPPORT LINE WAS CONTACTED, AND WHILE WAITING FOR ADDITIONAL HELP, DECIDED TO GRAB A DIFFERENT BLANKET (WHICH WAS A DIFFERENT LOT #). IT WAS LATER DISCOVERED THAT THE ISSUE WAS WITH THE BLANKET ITSELF, AND THE WATER NOT FLOWING THROUGH THE BLANKETS. AFTER ALL THE TROUBLESHOOTING AND SWITCHING OF MACHINES AND BLANKETS, THE INFANT PATIENT DID NOT REACH THE GOAL TEMPERATURE, THAT IS TYPICALLY ACHIEVED WITHIN 1 HOUR OF ARRIVAL, UNTIL ALMOST 6 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709495 BLANKETROL LLL SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 233 18588

    Patients

    Seq Age Sex Outcome Treatment
    1