BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLANKETROL III

    MDR report key: 2135035 · Received June 11, 2011

    Report

    Report Number
    1516825-2011-00007
    Event Type
    Other
    Date Received
    June 11, 2011
    Date of Event
    December 13, 2010
    Report Date
    May 13, 2011
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K101589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS ORIGINALLY RECEIVED ON (B)(4) 2011 ((B)(4)). AT THE TIME, CSZ DECIDED THAT THIS COMPLAINT DOES NOT QUALIFY TO BE REPORTABLE UNDER 803, AND HENCE NO MDR WAS SUBMITTED. ON (B)(6) 2011, CSZ RECEIVED A USER FACILITY REPORT (UFR) FROM FDA AND DECIDED TO SUBMIT A RESPONSE VIA MDR FORM 3500A. AT THE TIME OF ORIGINAL COMPLAINT REPORTING IN (B)(6) 2011, (B)(6), MET WITH (B)(6) ON (B)(6) 2011, AT THE FACILITY. (B)(6) REPORTED THAT THE ALLEGED "COLD BURN" WAS ACTUALLY JUST MARKING ON THE SKIN. THE PT APPARENTLY HAD MARKINGS ACROSS THE FRONT AND BACKSIDE OF THE HEAD AND TWO IMPRESSIONS ON THE BACK. THE HEAD MARKINGS WERE A RESULT OF THE HEAD WRAP BEING APPLIED TOO TIGHT AND THE MARKINGS ON THE BACK WERE A RESULT OF BEING POSITIONED DIRECTLY ON THE TWO HOSE CONNECTIONS ON THE PT VEST. THIS ISSUE IS AN APPARENT USER ERROR. (B)(6) HAS PROVIDED IN-SERVICE TO THE STAFF 3 TIMES PREVIOUSLY AND HAS OFFERED TO CONDUCT ADDITIONAL IN-SERVICING. ADDITIONALLY, CSZ CLINICAL CONSULTANT (B)(6), HAS ALSO IN-SERVICED THE STAFF AT THE FACILITY. AS A RESULT OF RECEIVING THIS UFR, CSZ, ON (B)(6) 2011, REQUESTED ADDITIONAL INFO FROM THE FACILITY DIRECTOR OF RISK MANAGEMENT BUT HAS NOT RECEIVED ANY INFO TO DATE. A FOLLOW UP REMINDER HAS BEEN SENT TO THE DIRECTOR OF RISK MANAGEMENT, AS SOON AS THE INFO IS RECEIVED AND FOUND TO BE DIFFERENT THAN WE HAD EARLIER, WE WILL SUBMIT SUPPLEMENTAL MDR ACCORDINGLY.

    Description of Event or Problem · 1

    CARDIAC ARREST PT WHO MET THE CRITERIA TO BE A CODE ICE SUSTAINED SKIN BREAKDOWN (FROST BITE TYPE BURN) FROM THE TUBES OF THE CINCINNATI MODEL BLANKETROL III UNIT TO THE BACK OF HIS HEAD, RIGHT THIGH, AND RIGHT MID BACK. THE COOLING WATER WAS NOT FLOWING THROUGH THE THERMASUIT UNTIL THE PT ARRIVED IN THE CRITICAL CARE UNIT (CVICU) FROM THE ED SO THE STAFF COULD NOT GET A TEMPERATURE UNTIL THE PT ARRIVED IN THE CVICU. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other