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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 Problem Device Sensing Problem (2917)
Patient Problem Not Applicable (3189)
Event Date 10/20/2020
Event Type  malfunction  
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 nurse tried to update vitals from night shift & asking how to view exact water temperature and patient temperature over the last 24 hours besides those on the graph. Current patient temperature sensitive to temperature decrease. Becomes brady & bp drops when below temperature 33c. Increased target temperature to 34c and patient temperature had been fine. Patient temperature was 32. 4c, water temperature was 40c. Later patient temperature was 32. 7c and water temperature was 40c. Night nurse made not of concern unit was not functioning correctly since patient temperature dropped below target temperature. Noted that exact temperature can be viewed via patient data download after therapy completed. Discussed potential causes for patient temperature to drop below target temperature. Nurse will review medications with physician to see if administering of medications correlates with temperature drop. Discussed use of bair huggers or blankets. Nurse notes they did apply blanket which seems to help, and patient had been stable. Noted that if the water temperature stays at 40c for an extended period they may receive safety alert. Explained this alert is a reminder to complete diligent skin checks.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key10733775
MDR Text Key213019134
Report Number1018233-2020-20423
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
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
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 Received10/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/26/2020 Patient Sequence Number: 1
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