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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 50000000E
Device Problems Insufficient Heating (1287); Overfill (2404)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/21/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the patient has dropped below target temperature and water temperature was not rising on arctic sun device. The patient temperature was 31. 4c, target temperature was 33c, water temperature was 23. 8c and flow rate was 2. 1 l/m. The patient was 55kg and had size small pads on. Also stated that four hours left to cool when patient started to drop with 2 bars trending downward. Patient received fentanyl and propofol. Nurse was unsure of any alerts. Mss walked through event log and they have received an alert 113 (reduced water temperature control) 4 times. Nurse noted that they had a power surge. Mss explained alert and accessed diagnostics. The outlet monitor temperature (t1) was 23. 7c, the outlet control temperature (t2) was 24c, the inlet temperature (t3) was 24. 4c, the chiller temperature (t4) was 11. 1c, water flow rate was 2. 1 l/m, inlet pressure was -7. 0 psi, circulation pump command was 53%, mixing pump command was 0% , heater was 100% , water reservoir level was 5, system hours were 203. 2 (checked twice) and pump hours were 1071. 0. Noted that device might be overfilled which could cause issues with being able to heat. Nurse noted after power surge, they received alert about adding water. Explained after a power surge to drain pads and check accurate water level. Mss walked nurse through draining water out of right drain port. The user restarted therapy and flow rate increased to stable 3. 2 l/m, water temperature increased from 21. 5c to 25. 2c in about 60 seconds. Also stated water temperature was continuing to increase and trend indicator now only shows one bar trending downward. Mss advised nurse to monitor and make sure water temperature continued to increase. The user would call back if any additional issues or concerns. Per follow up via nurse on (b)(6) 2021, medication administered as per hospital protocol.
 
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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 Key11826369
MDR Text Key250665464
Report Number1018233-2021-02805
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,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2020
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: 05/14/2021 Patient Sequence Number: 1
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