BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL II

    MDR report key: 1810637 · Received August 7, 2010

    Report

    Report Number
    1516825-2010-00009
    Event Type
    Malfunction
    Date Received
    August 7, 2010
    Date of Event
    June 23, 2010
    Report Date
    August 7, 2010
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE OPERATED AS INTENDED. UPON POWERING UP, THE DEVICE DEFAULTS TO 37 DEGREES CELSIUS. THE USER MUST SET THE TEMPERATURE FROM 37 DEGREES TO ANOTHER DESIRED TEMPERATURE AND SET THE DEVICE'S OPERATING MODE TO MANUAL OR AUTO. THE DEVICE'S DISPLAY PANEL INDICATES THE SELECTED MODE (MANUAL OR AUTO) BY A LIGHTED LED. THE OPERATOR'S MANUAL IN SECTION 3-4 INDICATES TO TURN THE UNIT OFF WHEN THE PATIENT'S TEMPERATURE IS .5 +/- 1 DEGREE ABOVE THE DESIRED TEMPERATURE TO AVOID COMPLICATIONS ASSOCIATED WITH THE TEMPERATURE DRIFT. THE OPERATORS MANUAL ALSO DESCRIBES "IN CAPITAL BOLD" HOW TO CHANGE FROM MANUAL TO AUTO MODE. THE CUSTOMER WILL BE NOTIFIED THE OPERATORS MANUAL DETAILS ON (B)(6) 2010. THE INSTRUCTIONS (OPERATORS MANUAL) PROVIDED WITH THE DEVICE WERE REVIEWED BY THE CSZ MEDICAL STAFF AND FOUND TO BE ADEQUATE. WE WILL FURTHER REVIEW OPERATORS MANUAL IN ITS ENTIRETY AND IF NECESSARY, MAKE CORRECTIONS.

    Description of Event or Problem · 1

    A MEDWATCH REPORT WAS RECEIVED ON (B)(6) 2010 WHICH STATED THAT THIS BLANKETROL 222R WAS BEING USED ON AN INFANT RECEIVING HYPOTHERMIA THERAPY TO MINIMIZE BRAIN INJURY. INFANT NOTED TO HAVE A CORE TEMPERATURE OF LESS THAN THE EXPECTED 33.5 C. INFANT WAS ASSESSED. COOLING BLANKET WAS ASSESSED AND FOUND TO BE SET AT 5 C MANUAL. IT HAD NOT BEEN SWITCHED TO 33.5 C AUTOMATIC. INFANTS CORE TEMPERATURE DROPPED TO 30 C. SHE WAS REWARMED AFTER BLANKET WAS RESET TO 33.5 X AUTOMATIC. INFANTS HEART RATE DECREASED TO 69 BPM, NO DYSRHYTHMIAS WERE NOTED. WHILE REVIEWING INSTRUCTION MANUAL FOR SETUP INSTRUCTIONS, IT WAS NOTED THAT THE NEED TO SWITCH FROM 5 C MANUAL TO 33.5 AUTOMATIC WAS NOT WRITTEN CLEARLY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLANKETROL II SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 222R

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA