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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 Chills (2191); Convulsion/Seizure (4406)
Event Date 01/01/2022
Event Type  Injury  
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 hypothermia patient was cooling on arctic sun device for about 2 hours and the 24 hour timer was counting down. Nurse stated that the device was set to start the 24 hour timer at the target temperature, but the patient had not reached the target temperature. Nurse stated that the target temperature was 36c, however, the target temperature was decreased to 33c after that it reached target temperature of 36c. Nurse stated that the patient temperature was 36. 1c, water temperature was 5. 6c and the flow rate was 2. 2l/min. Mss explained that the timer started when the patient reached the target temperature of 36c. Mss discussed the options of adjusting the timer back to 24 hours, when the patient reached 33c or starting the device as a new case with the target temperature of 33c. Nurse reported that the patient was generating heat due to seizure activity or shivering, they were assessing the patient, but had not addressed the heat generation yet. The nurse was not sure how long it may take the patient to reach 33c due to the heat generation, so the nurse wanted to start therapy as a new case.
 
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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 Key13374349
MDR Text Key285938861
Report Number1018233-2022-00190
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
Report Date 01/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
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 Received01/01/2022
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: 01/27/2022 Patient Sequence Number: 1
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