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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 Display or Visual Feedback Problem (1184); 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 rewarming on the arctic sun device. The nurse thought might be an additional water was needed. The patient temperature was 34. 6c and rewarmed from 37c at 0. 3c/hr to 37c. The flow rate was 2. 6lpm. The arctic sun device had an alert 03 (water reservoir low) and an alarm 15 (unable to obtain a stable patient temperature) present in event log from last night. The water level was 3 the pump hours were 1073. 1, the system hours were 1134. 8 and the heater command 100%. The nurse had emptied the arctic gel pads and the water level was full. The nurse did not thought that the water was added last night when they received an alert 03 (water reservoir low). Drained 400ml from circulation tank. The water temperature was increasing to mid 30cs before making adjustments. Rewarm from adjusted to current patient temperature at 34. 7c. Called back an hour later. The patient's nurse was in the background and stated that nurse had placed the arctic sun device in manual mode to 94f. Currently patient temperature was 34. 7c. Rewarmed from 35. 3c and the water temperature was 28. 3c. The user decided to change the arctic sun device. Asked nurse to have biomed check heater. Described how to set up new arctic sun device and reminded the user to empty the arctic gel pads first. Per follow up via nurse on (b)(6) 2020, they switched out devices and added a universal pad to complete therapy. The first device was sent to biomed.
 
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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 Key10614205
MDR Text Key214568054
Report Number1018233-2020-06283
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 03/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2018
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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