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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIS SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Device Alarm System (1012); Insufficient Cooling (1130)
Patient Problems Seizures (2063); Sepsis (2067); Patient Problem/Medical Problem (2688)
Event Type  Injury  
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 not cooling on the arctic sun device. There was an alert 52 and an alarm 53. The target temperature was 33c, the patient's temperature was 35. 2, the water temperature was 4. 8c and the flow rate was 1. 6lpm. The patient weighed 80. 9kg, and there was adequate coverage with the pads. The complainant noted that the patient was shivering and seizing and was being worked up for sepsis. She was about to begin a paralytic and the patient was already sedated. Ms&s discussed causes of heat generation and explained the device was responding appropriately. They disconnected and reconnected the pads and the flow rate rose to 1. 8lpm. The water was 4. 8c and the patient's temperature was 35c with the trend showing one arrow down. Ms&s discussed counter warming and to be diligent with skin checks. Per follow up via phone on 16mar2020, the charge nurse stated the issue was resolved. The device was in service and therapy was ongoing with no further issue.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIS 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 Key9914052
MDR Text Key188329114
Report Number1018233-2020-02218
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 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
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 Received05/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2011
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: 04/01/2020 Patient Sequence Number: 1
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