MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE

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.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: ARCTIC 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 Key: 13374349
• MDR Text Key: 285938861
• Report Number: 1018233-2022-00190
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• 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 Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/01/2022
• 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