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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Insufficient Cooling (1130); Intermittent Loss of Power (4016)
Patient Problems Alteration In Body Temperature (2682); 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 an alarm on the arctic sun device went off 10-12 times and kept shutting the device off. She stated that the nurse on the night shift kept silencing the alarm and turning therapy back on. The patient temperature was 34. 9c with a target temperature of 33c and six pads in place. The patient temperature was reading 34. 1 via esophageal probe. The patient was on shiver medication and antibiotics. Per troubleshooting with ms&s, the nurse was advised that the device would have to work harder due to the patient's weight. The nurse stated that there was not enough room for an additional gel pad. The nurse stated that she would discuss with the doctor to see if they can increase the target temperature to 34. 5c. Per follow up with nurse (b)(6) via phone on (b)(6) 2018, the patient reached target temperature and was currently continuing therapy in normothermia with no further issues. He confirmed that fentanyl was administered to the patient for shivering.
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Brand NameARCTIC SUN 5000
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
MDR Report Key8134021
MDR Text Key129396809
Report Number1018233-2018-05838
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
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 Received12/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2011
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: 12/05/2018 Patient Sequence Number: 1