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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problem Insufficient Cooling (1130)
Patient Problem Chills (2191)
Event Date 12/31/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the patient was not reaching the target temperature of 36 c on arctic sun device. The nurse stated that the patient was 37 c earlier and was notably shivering and added a bair hugger to the patient. The patient was given fentanyl but they were doing a continuous electroencephalogram (eeg) and the doctor did not want to paralyze the patient. The nurse decreased the target temperature to 34 c in a hope that it would bring the patient temperature down. The nurse stated that the trend had one arrow up water temperature was 5c the flow rate was 2. 8 lpm and medium pads plus universal pads were in place. There was a finger length of concave chest where the pads would not adhere well and the patient temperature was currently 37. 8 c. Ms and s discussed the source of heat generation and asked the nurse to address as per the facility protocol. The device was responding appropriately. Ms and s explained that by decreasing the target was not necessary unless they plan on leaving the temperature at 34 c. Ms and s asked the nurse to do the diligent skin checks.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13307409
MDR Text Key286665909
Report Number1018233-2022-00123
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/20/2022 Patient Sequence Number: 1
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