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

Model Number 50000000

Device Problems Device Alarm System (1012); Insufficient Cooling (1130)

Patient Problem Skin Discoloration (2074)

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 the patient was slow to cool while on the arctic sun device. The nurse noted an alert 52 (extended period of cold water) had been on and off all day and the patient's skin was getting red. The patient was on tylenol and antibiotics. The target temperature was 37. 3c, the patient temperature was 39. 7c and the flow rate was 2. 9lpm. The patient's weight was 126 kg and four arctic gel pad in total were in use. The two universal pads were around each high, one chest pad and one universal pad on the chest. The water temperature was 13c during the call but most of the day it has been around 4c. Mss explained large size pads were needed for the device to function properly for this size patient to have adequate body coverage. The nurse noted and would add the arctic gel pads. Per follow up via nurse on 20aug2020, the therapy was discontinued due to lack of effectiveness on patient and tried cooling blankets instead. Tylenol and antibiotics were administered due to patients condition and not the arctic sun device. Patient had neurogenic fever.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10514893
• MDR Text Key: 207514591
• Report Number: 1018233-2020-05797
• 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: 03/08/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• 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: 02/12/2021
• 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