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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 01/11/2022
Event Type  Injury  
Event Description
It was reported that the patient was not getting to target of 33c as quickly as expected in the arctic sun device. Also stated that they were not sure the device was working because the timer was not counting. Confirmed patient temperature was 36. 5c, target temperature was 33c, water temperature was 8. 5c and flow rate was 2. 1lpm. Nurse stated that therapy started approximately 30 minutes ago but they were not sure that the device was running. System diagnostics showed water level was 3, outlet monitor temperature (t1) was 9. 2c, outlet control temperature (t2) was 9. 2, inlet temperature (t3) was 12. 0, chiller temperature (t4) was 5. 5, ip -7. 0psi, circulation pump command was 61 percentage, mixing pump command was 100 percentage, system hours were 8275, pump hours were 7924. Trend indicator showed one arrow up. Also confirmed protocol in device set to start timer at target. Mss explained that the 24 hours would start to count down once the patient was at 33c. Also advised that the device appeared to be working appropriately. Patient was likely generating heat, and therapy had not been in place long enough for temperature to be at target. Mss discussed trend indicator, non-pharmacological interventions such as bair hugger to help with heat generation, also discussed with nurse to look at hospital protocol regarding options for pharmacological interventions based on patients bsas and temperature. The nurse stated that they was not very sedated and they could feel micro shivering in the mandible. Per follow up via phone on 19jan2022, the nurse stated that the therapy was completed with no further issues and the arctic sun did not need to go to biomed.
 
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® 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 Key13415534
MDR Text Key285738911
Report Number1018233-2022-00278
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 Other Health Care Professional
Type of Report Initial
Report Date 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2022
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 Received01/11/2022
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: 02/01/2022 Patient Sequence Number: 1
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