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

Model Number 50000000

Device Problem Insufficient Cooling (1130)

Patient Problems Seizures (2063); Convulsion/Seizure (4406)

Event Date 10/22/2020

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 patient was not cooling on the arctic sun device. The lines had condensation on them. Ms&s stated if the water was cold it was possible to have condensation on the tubing. The patient weighed (b)(6) kg with large arctic gel pads and a universal in place. The nurse wondered if nurse should add more universal pads to his thighs. Ms&s confirmed abdomen was well covered. The patient temperature was 33. 8c, the target temperature was 33c, the flow rate was 3. 5lpm, the water temperature was 9c, and the trend showed two arrows down. The nurse confirmed patient was sedated, but experienced some myclonic jerking. Ms&s explained this was causing patient to generate heat and should check facility protocol /consult with md. Later on, the patient temperature was 32. 8c and the condensation was gone.

• 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: 10836997
• MDR Text Key: 216150822
• Report Number: 1018233-2020-20940
• 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: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 11/13/2020 Patient Sequence Number: 1