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

Model Number 50000000E

Device Problems Insufficient Cooling (1130); Display or Visual Feedback Problem (1184)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 arctic sun device received an alert 52 (extended period of cold water). The cooling was started 6 hours ago. The target temperature was 33c. The patient temperature was 36. 1c at the start of the call by the end it was 36c. The water temperature was 5c and the flow rate was 3. 1 l/m. The 5 pads were in good coverage. The esophageal probe in place. The second temperature source correlating and the bair hugger in place, according to the protocol. On a low setting no shivering was noted, according to the nurse. The trend was in middle at the start of the call, 1 bar down. The nurse checked the patient's skin and appears to be fine. The nurse explained the machine was doing what it should be. The nurse will speak to the doctor regarding the infection and possibly will start the (b)(4). Ms&s instructed the nurse to call back when the alarm goes off again or for any other issues. The nurse was aware of the possible skin issues when the water was too low for too long.

• 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: 10619774
• MDR Text Key: 215114377
• Report Number: 1018233-2020-06302
• 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: 03/31/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse