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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problem Insufficient Cooling (1130)
Patient Problems Confusion/ Disorientation (2553); 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 device was not cooling a hypothermia patient. The target temperature was 33c. Sedatives were given but the patient was not paralyzed and was moving a lot then a paralytic was given. The nurse noticed there was a cool patient box blinking at the bottom of the screen and became confused. Ms&s explained the cool patient box will gray in and out when the device is running. Cooling settings were confirmed. Patient temperature was 37. 7c, water temperature was 41. 7c and the flowrate was 2. 3lpm. The patient weighed over 100 kgs and their abdomen was exposed. Ms&s explained the importance of following their facility's drug protocol for sedation and paralytics in order for the patient to reach the target temperature within their protocol time frame. Ms&s recommended that the nurse add a universal pad to the lower abdomen and discussed counter warming. Per follow up on (b)(6) 2019, the nurse stated the male patient was able to complete therapy and that the drugs administered were per hospital protocol for initiating therapy.
 
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Brand NameARCTICSUN 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 Key9410693
MDR Text Key169142758
Report Number1018233-2019-07687
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
Type of Report Initial,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
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 Received01/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
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: 12/04/2019 Patient Sequence Number: 1
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