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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 50000000L
Device Problems Insufficient Heating (1287); Temperature Problem (3022)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 was not heating on the arctic sun device. They did not believe patient was rewarming. Patient temperature was 34. 3c, water temperature was 27. 4c, flow rate was 2. 8 l/m, and target temperature was 37c. The patient weighed about (b)(6) kg and was using large sized pads. There was no exposed abdomen. Rewarm rate was 0. 23l/m. T1 was 27. 7c, t2 was 28. 3c, t3 was 25. 7c, t4 was 12. 8c, water flow rate was 2. 7 l/m, and inlet pressure was -7. 2 psi. Circulation pump command was 69%, mixing pump command was 0, heater was 100%, water level reservoir was 5, system hours were 1797. 4 and pump hours were 1523. 6. Ms&s walked nurse through placing device in manual mode at 42c. The device ran for 15 minutes and temperature did not rise above 27. 6c. Nurse stated they had another device available and will swap out patient. Per follow up 1 on 18aug2020, stated that the patient was placed onto a second device where there were no further issues.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key10469214
MDR Text Key219192038
Report Number1018233-2020-05554
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000L
Device Catalogue Number50000000L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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