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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE (INTREPID) Back to Search Results
Model Number 50000000E
Device Problems Unexpected Therapeutic Results (1631); Patient-Device Incompatibility (2682)
Patient Problems Shaking/Tremors (2515); 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.
 
Event Description
It was reported that the patient was not responding appropriately to treatment on the arcticsun device during an intrepid study. The patient was intubated and received treatment of propofol, etomidate, rocuronium, nimbex, fentanyl ggt, midaz ggt, skin counter warming, and acetaminophen to control shivering. The shivering was in response to being on the device and the patient had difficulty regulating shivering after the device was removed. Therapy was not able to be completed and the device was not swapped. The patient also received treatment for icp (increased intracranial pressure).
 
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Brand NameARCTICSUN 5000
Type of DeviceARCTIC SUN DEVICE (INTREPID)
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 Key9489435
MDR Text Key172193834
Report Number1018233-2019-08057
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 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
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 Received02/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2016
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: 12/18/2019 Patient Sequence Number: 1
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