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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 6000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 6000 ARCTIC SUN DEVICE Back to Search Results
Model Number 60000000
Device Problem Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2021
Event Type  malfunction  
Event Description
It was reported that the normothermia patient was on arctic sun device for fever control. The nurse reported the device has been alarming all the day. The patient temperature was 37. 9 c the target temperature was 37. 5 c but it was lowered to 36. 5 c and they thought it would cool the patient better. A four large pads were in place with good coverage and the patient weight with 83. 3 kgs. The water temperature was 6. 2 c the flow rate was 2. 5 lpm and the bair hugger was in place. The event log showed multiple alerts 52 (extended period of cold water) and alarm 53 (prolonged cold water exposure). Ms and s discussed the probable cause of the alarm and alert heat generation and importance of prompt treatment. The nurse admitted the patient has been shivering intermittently all the day. Ms and s explained how the shivering and heat generation leads to cold water exposure as the device worked to cool the patient. It was directed to work to cool function on the screen and explained what it means when the orange bars appear. The nurse confirmed that the device has a good flow rate and the water was cold. The device was responding appropriately to changes in the patient temperature. Ms and s advised to be diligent with skin checks as prolonged cold water exposure may increase the risk of skin injury. The patient will administer shivering medications as per protocol. It was recommended to discuss the prolonged cold water exposure with the physician.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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Brand NameARCTIC SUN® 6000
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 Key13181884
MDR Text Key283395942
Report Number1018233-2021-08721
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200225
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 12/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60000000
Device Catalogue Number60000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2021
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: 01/06/2022 Patient Sequence Number: 1
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