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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 50000000
Device Problem Insufficient Heating (1287)
Patient Problems No Known Impact Or Consequence To Patient (2692); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/27/2021
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 hypothermia patient temperature was continuing to drop below target while undergoing therapy on arctic sun device. At beginning of shift, the patient temperature was 32. 8c but now the patient temperature was 31. 8c. The target temperature was 33c, the water temperature was 41. 1c and the flow rate was 2. 7 l/m. There was good pad coverage with no exposed abdomen. Also stated that the patient was not on continuous renal replacement therapy (crrt) and the indicator showing 3 bars trending downward. The patient was on propofol, versed, fentanyl and insulin. The patient was on bair huggers and blankets. Discussed effects of medications on patient temperature and trend indicator. Noted that the arctic sun device appeared to be responding to patient appropriately. Advised to consult medical team to evaluate patient issue. Per follow up via nurse (b)(6) on 01feb2021. Patient was able to complete therapy. Vents and warm blankets also used to warm patient. Medication administered to control movement. The arctic sun device already moved so nurse was unable to provide serial number and no additional information available.
 
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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 Key11363086
MDR Text Key233077931
Report Number1018233-2021-00684
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 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
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 Received10/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/22/2021 Patient Sequence Number: 1
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