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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 Device Sensing Problem (2917); Infusion or Flow Problem (2964); Temperature Problem (3022)
Patient Problems Hypothermia (1915); 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. The device was not returned.
 
Event Description
It was reported that the patient was not cooling on the arctic sun device. The nurse tried to figure out what happened last night and throughout the day. The nurse restarted therapy around 8 pm to decrease the patient's temperature and also found there was a lot of condensation on the pads and tubing. Foley probe was in use. The patient was 36. 0c. Target was 33c. Water was 5. 6c. But esophageal probe to bedside read 37. 7c. The device was beeping, but there was no error message on the display. Earlier they received alert 50, but that occurred when the nurse wrapped a chuck around the foley. The patient was on target of 33c last night, but the nurse stated the device stopped because the water was too cold. Ms&s asked the nurse to cycle the power and the beeping was resolved. Ms&s discussed alarm 53 and how therapy would stop as a safety feature. The patient was active shivering. As per the follow-up information, it was stated that once they were able to get the patient's shivering under control they were able to maintain temperature and continue therapy with no further issues.
 
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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 Key10273172
MDR Text Key200047142
Report Number1018233-2020-04509
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received08/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
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: 07/14/2020 Patient Sequence Number: 1
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