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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 Problems Device Alarm System (1012); Insufficient Cooling (1130)
Patient Problem Skin Discoloration (2074)
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 patient was slow to cool while on the arctic sun device. The nurse noted an alert 52 (extended period of cold water) had been on and off all day and the patient's skin was getting red. The patient was on tylenol and antibiotics. The target temperature was 37. 3c, the patient temperature was 39. 7c and the flow rate was 2. 9lpm. The patient's weight was 126 kg and four arctic gel pad in total were in use. The two universal pads were around each high, one chest pad and one universal pad on the chest. The water temperature was 13c during the call but most of the day it has been around 4c. Mss explained large size pads were needed for the device to function properly for this size patient to have adequate body coverage. The nurse noted and would add the arctic gel pads. Per follow up via nurse on 20aug2020, the therapy was discontinued due to lack of effectiveness on patient and tried cooling blankets instead. Tylenol and antibiotics were administered due to patients condition and not the arctic sun device. Patient had neurogenic fever.
 
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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 Key10514893
MDR Text Key207514591
Report Number1018233-2020-05797
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 03/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2020
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 Received02/12/2021
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

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