BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL III

    MDR report key: 6102653 · Received November 15, 2016

    Report

    Report Number
    6102653
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    September 3, 2016
    Report Date
    September 30, 2016
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, LLC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRIOR TO THE INFANT'S ADMISSION, A BLANKETROL WAS SETUP PER INSTRUCTIONS IN OUR POLICY FOR COOLING. INFANT ARRIVED AND WAS PLACED ON BLANKET. AFTER PRE-COOLING LABS WERE DRAWN AND SENT, BLANKETROL WAS SWITCHED TO AUTOMATIC CONTROL MODE TO BEGIN THE COOLING PROCESS. THE BLANKETROL ALARMED AND THE SCREEN READ "CHECK PT PROBE." THE BLANKETROL SHUT OFF AND WAS SWITCHED OUT WITH NEW BLANKETROL. THE SAME STEPS FOLLOWED PER POLICY FOR NEW BLANKETROL AND IT WORKED PERFECTLY. THERE WAS ONLY A DELAY OF ABOUT 5 MINUTES OF COOLING BUT INFANT WITH STILL WITHIN 6 HOUR COOLING WINDOW. THE BLANKETROL MACHINE WAS TAGGED AND PREPARED TO BE SENT TO CLINICAL ENGINEERING FOR EVALUATION. MANUFACTURER RESPONSE FOR BLANKETROL, BLANKETROL (PER SITE REPORTER): CLINICAL ENGINEERING RECEIVED A BLANKETROLL HYPO/HYPERTHERMIA THAT WAS INVOLVED IN AN INCIDENT, THE OCCURRENCE NUMBER I HAVE IS (B)(4). AFTER CONDUCTING A THOROUGH INVESTIGATION WITH THE DEVICE AND TESTING ALL THE FUNCTIONS AND ACCESSORIES, I CAME TO THE CONCLUSION THAT THERE IS AN ISSUE WITH THE PATIENT CABLE. THE PATIENT TEMPERATURE ON THE DISPLAY WOULD GO IN AND OUT AS THE CABLE WAS MOVED WHICH WILL PREVENT THE DEVICE FROM GOING INTO AUTO CONTROL MODE AS THE UNIT HAS TO SEE A PATIENT TEMPERATURE BETWEEN 30C AND 43.5C. IF IT DOES NOT SEE THIS TEMPERATURE, WHICH IT DID NOT BECAUSE THE CABLE WAS FAULTY, IT WILL NOT GO INTO AUTO CONTROL MODE. I HAVE ORDERED A NEW PATIENT CABLE THROUGH CINCINNATI SUB ZERO AND HAVE SEQUESTERED THE OLD CABLE AT MY DESK. I WILL KEEP YOU UPDATED AS TO WHEN THE NEW PATIENT CABLE ARRIVES AND THE FINAL TESTING AND CONCLUSION OF THE INCIDENT IS COMPLETED. SEPTEMBER UPDATE: I RECEIVED THE REPLACEMENT PATIENT CABLE TODAY FOR THE BLANKETROLL III AND WHEN THE UNIT WAS TURNED ON, IT ALARMED "CHECK FLOW SWITCH" I SPOKE TO THE MANUFACTURER AND THEY RECOMMENDED CLEANING THE FLOW SWITCH TO CLEAR THE ERROR. AFTER I PERFORMED THE CLEANING STEPS AS INSTRUCTED BY THE MANUFACTURER, THE ERROR HAD CLEARED. WITH THE NEW PATIENT PROBE ATTACHED, THE PERFORMANCE TEST PASSED AND NO ISSUES WERE NO LONGER FOUND. I HAVE DOCUMENTED ALL OF THE REPAIR PROCEDURES AND PARTS IN THE WORK ORDER. I WOULD LIKE YOUR PERMISSION TO RELEASE THIS BACK INTO SERVICE AS ALL THE PREVENTATIVE AND PERFORMANCE TESTING HAS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754610 BLANKETROL III SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR NO| NO OTHER THERAPIES