BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOL-CAP

    MDR report key: 6062128 · Received October 27, 2016

    Report

    Report Number
    3018859-2016-00024
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    NATUS MEDICAL INC
    Product Code
    MXM
    PMA / PMN Number
    P040025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) WILL CONTINUE TO UPDATE THE COMPLAINT AS NECESSARY WITH ADDITIONAL INFORMATION WHEN IT'S AVAILABLE. CONCLUSION, BASED ON INFORMATION COLLECTED FORM THE CUSTOMER REGARDING DESCRIBED EVENT, (B)(4) IS CONCLUDING THAT A PATIENTS DEATH RESULTED FROM PATIENT'S UNDERLYING CONDITION AND WAS NOT RELATED TO FUNCTIONALITY OF NATUS COOL-CAP SYSTEM. NOT REQUESTED, NO MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT LOW RECTAL ALARM WAS RECEIVED AS A RESULT OF PATIENT'S TEMPERATURE DROPPING BELOW RECOMMENDED RANGE. BASED ON THE COMMUNICATION BETWEEN TECHNICAL SERVICE AND CUSTOMER, THE OLYMPIC COOL-CAP SYSTEM OPERATED PER SPECIFICATIONS TRIGGERING THE A15 ALARM FOR VERY LOW RECTAL TEMPERATURE WHEN THE RECTAL TEMPERATURE DROPPED BELOW RECOMMENDED TEMPERATURE RANGE OF 34.5 ±0.5°C. THERE WERE MULTIPLE CALLS MADE BETWEEN TECHNICAL SERVICE AND THE CUSTOMER AS PART OF TROUBLESHOOTING TO BRING THE TEMPERATURE WITHIN RECOMMENDED RANGE. TECHNICIAN NOTED THAT WHILE TALKING TO A CUSTOMER, IT WAS MENTIONED THAT THE PATIENT WAS A HOME BIRTH DELIVERY GONE TERRIBLY WRONG. THE PATIENT DID NOT RECEIVE ANY MEDICAL ATTENTION FOR AT LEAST ½ HOUR. ALSO, DURING THE CALL THE CUSTOMER CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE COOL CAP SYSTEM. THE ACTIONS SUGGESTED BY TECHNICAL SERVICE AND TAKEN BY THE FACILITY TO INCREASE THE RECTAL TEMPERATURE FROM 32.9°C TO THE RECOMMENDED RANGE OF 34.5 ±0.5°C FOLLOWED THE ACTION PLAN DOCUMENTED IN TROUBLESHOOTING GUIDE FOR A COOL-CAP SYSTEM. DURING APPROXIMATELY TWO HOURS OF COMMUNICATION BETWEEN THE CUSTOMER AND TECHNICAL SERVICE REPRESENTATIVE, THE RECTAL TEMPERATURE INCREASED FROM 32.9°C TO ABOVE 34.1°C. DURING THE LAST CALL TO FOLLOW-UP ON THE PATIENT STATUS, CUSTOMER STATED THAT THE PATIENT PASSED AWAY, AND THAT PATIENT'S RECTAL TEMP PRIOR TO PASSING WAS STILL IN TARGET RANGE OF 34.3°C. BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER, THERE'S NO INDICATION THAT OLYMPIC COOL-CAP SYSTEM MALFUNCTIONED. (B)(4) MADE MULTIPLE CONTACT ATTEMPTS IN ORDER TO OBTAIN ADDITIONAL INFORMATION PERTAINING TO REPORTED EVENT, DEVICE INFORMATION AND PATIENT'S DIAGNOSIS AND TREATMENT HISTORY. AS OF (B)(6) 2016, THERE HAVE BEEN NO UPDATES FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712662 COOL-CAP COOL-CAP MXM NATUS MEDICAL INC 401701-501

    Patients

    Seq Age Sex Outcome Treatment
    1 Death