BEUDAMED
    FDA Adverse Event Other Summary report: N

    INNERCOOL

    MDR report key: 1999187 · Received January 17, 2011

    Report

    Report Number
    1516825-2011-00001
    Event Type
    Other
    Date Received
    January 17, 2011
    Date of Event
    September 11, 2009
    Report Date
    September 25, 2009
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K101589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL BY PHILIPS MEDICAL INDICATES THAT THERE WAS NO MALFUNCTION OF THE COOL BLUE UNIT. THE PT APPARENTLY SUFFERED A "FREEZER BURN" DUE TO LACK OF ANTI-SHIVERING MEDICATIONS WHEN COOLING WAS FIRST INITIATED. THE PT BURNS HEALED WITH THE USE OF TOPIC OINTMENT. CSZ DEVICE WORKED AS INTENDED; CSZ DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. NO FURTHER ACTION IS TAKEN. NOTE: THIS MDR IS BEING FILED AS A RESULT OF RESPONSE TO SUBSEQUENT AUDIT FINDINGS REQUIRED IN THE WARNING LETTER (B)(4) 2010. ADDITIONAL INFO FROM VOLUNTARY REPORT: PRODUCT AVAILABLE FOR EVAL: YES, INNERCOOL, CATALOG# NA, (B)(4). THE REPORTER DOES WANT THEIR IDENTITY DISCLOSED.

    Description of Event or Problem · 1

    HYPOTHERMIA INITIATED (B)(6) 2009 AT 1602, FOLLOWING CARDIAC ARREST AND SEIZURES. REWARMING INITIATED ON (B)(6) 2009 AT 2230. INNERCOOL WAS DISCONTINUED ON (B)(6) 2009 AT 1845. NOTED IMPAIRMENT TO SKIN INTEGRITY. SIZE, PATTERN, AND LOCATION WERE CONSISTENT WITH THE INNERCOOL PADS. POSTERIOR THIGHS BILATERALLY PALE ASHEN EPIDERMIS WITH SIGNIFICANT BLISTERING WITH SOME SLOUGHING. WOUNDS MEASURED 20CM X 20CM. LEFT THIGH OPEN AREA MEASURED 7CM X 18CM. RIGHT THIGH OPEN AREA MEASURED 5CM X 8CM. INJURIES APPEARED CONSISTENT WITH PARTIAL THICKNESS THERMAL INJURY. POSTERIOR THORAX WITH PALE EPIDERMIS AND BLISTERS SIMILAR TO THE PATTERN OF THE FLUID CHANNELS IN THE INNERCOOL PADS. AREA MEASURED 50CM X 35CM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNERCOOL THERMAL REGULATING SYSTEM DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 25-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other