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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Device Alarm System (1012); Insufficient Cooling (1130)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 cooling on the arctic sun device. The device displayed alert 113. Patient temperature was 35. 3c, target temperature was 33c, and water temperature was 29. 7c. Flow rate was 2. 8lpm and the water level was 4. Therapy was stopped and placed device in manual control at 4c. T1 was 29. 7c, t2 was 29. 7c, t4 was 3. 2c, and mixing pump was at 100%. System hours were 7692 and pump hours were 7330. Manual control was stopped, pads were emptied and the machine was sent to biomed. The nurse had another machine she could use. Per follow up via phone on 30jan2020 charge nurse stated, they had to swap devices and the patient was still completing therapy on the 2nd device with no further issues. The 1st device was sent to biomed.
 
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Brand NameARCTICSUN 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 Key9740189
MDR Text Key184144104
Report Number1018233-2020-01248
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2020
Is this an Adverse Event Report? No
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 Received03/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
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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