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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN DEVICE Back to Search Results
Model Number 60000000
Device Problems Insufficient Heating (1287); Overfill (2404)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the nurse stated the patient was not rewarming on the arctic sun device. The nurse wanted to know if the device was working appropriately. The patient temperature was 33. 6c, target temperature was 37c, water temperature was 30. 4c and flow rate was 3. 0lpm. Rewarm from 35. 5 c and rewarm rate was 0. 33c/hour. When mss walked the nurse through alerts and alarms, alert 113 (reduced water temperature control) was noted. Operating hours were 73, system hours were 102 and heater command was 100 percent. Mss explained how to drain 500 cc off the device and placed the device in manual control with water temperature at 40c. Water temperature immediately went to 38c, and nurse disabled manual mode. Now the patient temperature was 33. 8c and water temperature was 37c.
 
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Brand NameARCTIC SUN DEVICE
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 Key13434146
MDR Text Key286167150
Report Number1018233-2022-00347
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741161513
UDI-Public(01)00801741161513
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200225
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 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60000000
Device Catalogue Number60000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2021
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: 02/02/2022 Patient Sequence Number: 1
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