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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 50000000E
Device Problem Insufficient Cooling (1130)
Patient Problem Chills (2191)
Event Date 12/19/2021
Event Type  Injury  
Event Description
It was reported that the target temperature had been 33c, but the patient temperature was 35. 4c all night while using the arctic sun device. The nurse adjusted to the target temperature 35c but now getting alarm 53 prolonged cold-water exposure. The log showed multiple alert 52 extension period of cold water and alarm 53. The patient had on 5 pads and no flow problems. They are treating infection with antibiotics and tylenol. The vent circuit set for 35c. The patient was shivering. They would control for shivering and discuss vent circuit heater. Per follow up information received on 29dec2021, the device was in use on the patient. Patient was able to complete therapy on device after they were able to treat patient's shivering. Patient was not harmed during therapy. Device was still in use after she left her shift, no other information known.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
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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 Key13162808
MDR Text Key283330090
Report Number1018233-2021-08684
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 Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
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
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
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: 01/05/2022 Patient Sequence Number: 1
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