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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 2000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 2000 ARCTIC SUN DEVICE Back to Search Results
Catalog Number 2000-00
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 arctic sun device was slow to rewarm. Nurse stated that the patient started rewarming this morning about 2 hours ago. The target temperature was 36. 5c, the patient temperature was 33. 2c, the water temperature was 30. 7c and the flow rate was 3. 3 l/min. Patient weighs 114 kgs and 4 medium arctic gel pads were in place. Nurse stated there was one of the chest pads placed longitudinally across the chest. The other arctic gel pads were placed appropriately. Rewarm rate was 0. 3c/hour. Nurse was concerned that the patient should be approximately 33. 6c, so they changed the rewarm settings several times to help the patient to reach that temperature. The patient was not on continuous renal replacement therapy (crrt). Explained that the patient should have at least 4 large arctic gel pads and 1 universal pad in place due to weight. Discussed importance of adequate arctic gel pad coverage and arctic gel pad placement. Explained how the arctic sun device uses an algorithm to provide therapy and every time the setting was changed the arctic sun device had to reconfigure the algorithm. Advised not to change the settings. Suggested to cover the patient's hands, head and feet and add a warm blanket if user was concerned about the slow rewarm and arctic gel pad coverage was not adequate. Nurse stated he would obtained and placed a universal arctic gel pad on the patient. Called nurse back in approximately 1 hour and stated that had placed 2 universal pads across the patient's exposed abdomen. The patient temperature was 33. 4c, the flow rate was 3. 6 l/min and the water temperature was 34. 8c. Confirmed that the arctic sun device was responding appropriately and would call back if had further questions.
 
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Brand NameARCTIC SUN 2000
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 Key10614208
MDR Text Key212367800
Report Number1018233-2020-06284
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 Catalogue Number2000-00
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 Received03/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2010
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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