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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 Insufficient Cooling (1130)
Patient Problem Insufficient Information (4580)
Event Date 03/17/2022
Event Type  Injury  
Event Description
It was reported that the therapy was initiated around 3. 30pm using arctic sun device (s/n (b)(4). The patient was not at target yet. Target temperature was 36c, patient temperature was 36. 9c, and flow rate was 3. 1lpm. Large patient with universal pad on the abdomen. The chest was open from the nipple line up, but otherwise well-covered. Low water limit was set to 4c and discussed the causes of heat generation. The trend was pointing up, but was now neutral. Patient was sedated with propofol, but was not paralyzed. They were checking for seizure activity. They just gave fentanyl about 5-10 minutes ago. Mss suggested to continue to follow their protocol for heat generation and suggested counter-warming. Device was responding appropriately. Mss continued to do frequent skin checks due to the cold water.
 
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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key14115963
MDR Text Key289320743
Report Number1018233-2022-02491
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 Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
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
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2013
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: 04/14/2022 Patient Sequence Number: 1
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