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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 Insufficient Cooling (1130); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seizures (2063); Chills (2191); 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. (b)(4).
 
Event Description
It was reported that the patient was not cooling on the arctic sun device. The hypothermia patient was cooling for 2 hours. The nurse stated that the flow was showing as 'marginal' and the patient was slow to cool. The patient temperature was 97. 8f (36. 5c), the target temperature was 91. 4f (33c), the water temperature was 42. 4f(5. 8c) and the flow rate was 1. 8l/min. There were four large arctic gel pads in place with some exposed abdomen. The patient weighed (b)(6) lbs. Nurse administered fentanyl and versed. Nurse stated that there was no signs of shivering. Ms&s explained that the flow rate of 1. 7l/min or greater is acceptable, however, the arctic sun device might displayed 'marginal flow' on the screen saver. Ms&s discussed adding an additional universal pad to the abdomen. The patient trend indicator showed 2 arrows down and 1 hour later, the patient was now at 35. 9c and the water temperature was -5. 2c. The user observed shivering or possibly seizure activity and administered a paralytic (norco). The patient trend indicator showed 2 arrows down and during the call it went to thermoneutral. Ms&s advised to be diligent with skin checks. Bair hugger was already in place for counter warming and the therapy continued. Additional information was received from biomed via technical support on 27jul2020. Per technical support, the device checked out fine and was put back into service.
 
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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 Key10404547
MDR Text Key202857335
Report Number1018233-2020-05168
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 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
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 Received11/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2014
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: 08/13/2020 Patient Sequence Number: 1
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