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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN DEVICE Back to Search Results
Model Number 60000000
Device Problem Insufficient Cooling (1130)
Patient Problem Chills (2191)
Event Date 01/20/2022
Event Type  malfunction  
Event Description
It was reported that the arctic sun device was getting an alert 117 (patient temperature 1 change not detected), and restarted from force stop. Target temperature was 36c, patient temperature was 37. 5c, flow rate was 2. 9lpm, water temperature was 5. 7c, system hours were 737. 5, pump hours were 651. 2, outlet monitor temperature (t1) was 5. 7c, outlet control temperature (t2) was 5. 7c, inlet temperature was 10. 3c, chiller temperature was 4. 0c, inlet pressure was -7. 5psi (settling after restart), circulation pump command was 79 percent and mixing pump command was 0 percent. Nurse stated that patient was shivering and was not on any sedation. Mss advised that the water returning to the device was much warmer than the water flowing out of the device and discussed heat generation and non- pharmacological interventions such as bair hugger. Mss also discussed on consulting their protocol for shiver management. Nurse had also filled the device without an alert when they got this device. Water level was 5 bars, drained 500ml from the right drain port. 15 minutes later, patient temperature was dropping 36. 9c and water temperature was 5. 8c. No new alerts or alarms noted. Per follow up information received on (b)(6) 2022, nurse stated that therapy was completed successfully with the second arctic sun device. Nurse stated they labeled the first arctic sun device to be picked up by biomed. There was no impact to the patient.
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
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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
juan velez
8195 industrial blvd
covington 30014
MDR Report Key13527922
MDR Text Key288692080
Report Number1018233-2022-00605
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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,Followup
Report Date 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
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 Received07/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2020
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: 02/14/2022 Patient Sequence Number: 1