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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 Problems Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/14/2022
Event Type  Injury  
Event Description
It was reported that a normothermia patient started therapy at 41c, current patient temperature was 40. 1c on the arctic sun device. The physician changed settings from target temperature 37c to 34c. Nurse wanted to confirm the device was working correctly. The water temperature was 5. 7c, flow rate was 2. 0 lpm. The patient was sedated, but they were about to give paralytics and nurse denied shivering, microshivering or seizures and patient was septic. The trend showed 3 bars trending upward and rewarm rate set to maximum. There were size large pads, but only 3 pads were connected. The patient had line in that was going to be removed and then 4th pad would be added. Mss advised nurse to go ahead and attach pad to device by lay it aside if it could not be placed on the patient yet. There was no exposed abdomen. The flow rate increased to 2. 8lpm. The device appeared to be responding to the patient temperature appropriately. In addition of the 4th pad adds surface area coverage and should assist with temperature management. They might receive low water temperature exposure alerts if water temperature continued to stay so low. Mss explained nurse this alert was a safety alert and encourages diligent skin checks according to hospital protocol. Per follow up information received via phone on (b)(6) 2022, nurse stated that the device continued to work correctly, the 4th pad mentioned in the call was connected and patient continued therapy. There are no known reported injuries.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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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 Key14914598
MDR Text Key295231223
Report Number1018233-2022-05111
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
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
Report Date 06/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
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 Received06/14/2022
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: 07/05/2022 Patient Sequence Number: 1
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