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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 6000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 6000 ARCTIC SUN DEVICE Back to Search Results
Model Number 60000000
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/03/2022
Event Type  malfunction  
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 (b)(6) hypothermia patient cooling on the arctic sun device (serial (b)(4)) for several hours. Nurse reported that the device lost power and seemed to have trouble loading the software. The screen was yellow. They were not the nurse who did the troubleshooting, so information was limited. Nurse restarted the device and started the treatment over instead of resuming current patient. Nurse wanted to make sure the settings were correct. Rectal probe was in place. Target temperature was 36c, patient temperature was 37c, water temperature was 8. 2c and flow rate was 2. 2lpm. Four small arctic gel pads were in place. Patient weighed 60 kilograms. Nurse stated the pads provided good coverage. Event log showed one alarm 45 (ac power lost low priority alarm- the ac power was lost while the power switch was in the ¿on¿ position). Mss explained this alarm. The nurse stated the device might have been plugged into the bed. Currently the device was plugged into a wall outlet. Mss explained that plugging the device into a bed could lead to power loss. The cool patient was set to cool for 69 hours. Mss explained that it appeared the device was programmed for a neonate, thus the 69 hours of cooling was left and patient cooling for 3 hours. Mss recommended the nurse to speak to the patient's doctor regarding cooling time. Nurse stated that for older children they use the adult protocol and adjusted the cooling time to 24 hours. Nurse would also verify with the doctor. Mss discussed causes of heat generation. The nurse stated the patient had been shivering for some time. They recently increased sedation and shivering had stopped. The device had a good flow rate and water was cold. The device had a good flow rate and water was cold. Mss advised to be diligent with skin checks. The device was working as programmed. Mss also recommended the nurse change out the device if the power loss reoccurred. During the second call from facility, nurse called to let them know that the arctic sun device (serial (b)(4)) stopped again. The nurse reported that the device displayed something about load program not responding, close program. Nurse closed the program, and the device displayed a yellow screen and device displayed a message about communication disabled or disconnected. Nurse cycled the power, and the device was beeping intermittently. Rectal probe was in place and the patient temperature was confirmed with another source. Event log only showed one alarm 45 (ac power lost low priority alarm- the ac power was lost while the power switch was in the ¿on¿ position). Mss recommended the nurse to change out the device and send this one to the biomedical engineering department for evaluation. Mss walked the nurse through switching to another arctic sun device (serial (b)(4)) and adjusting cooling time to 15 hours. Low water temperature limit was 8c, patient temperature was 37. 2c, target temperature was 36c, flow rate was 2. 3lpm and water temperature was 12c. Mss discussed heat generation again and explained the work to cool function. Electroencephalogram (eeg) showed no seizure activity. Mss discussed the importance of heat generation management as the water was cold. The nurse reported that the patient had been cooling since 2pm yesterday. Mss advised to be diligent with skin checks. There were no obvious signs of shivering. The nurse stated that the patient was sedated. Nurse would speak to the doctor about management of the heat generation and counter warming.
 
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Brand NameARCTIC SUN® 6000
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 Key14251785
MDR Text Key290445580
Report Number1018233-2022-03137
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200225
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 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60000000
Device Catalogue Number60000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2022
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: 04/29/2022 Patient Sequence Number: 1
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