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

Model Number 50000000

Device Problems Device Alarm System (1012); Insufficient Heating (1287)

Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)

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 to heating on the arctic sun device. The patient cooled, coded, and started to rewarm. The patient had vascular issues. They were getting alarm 115. Patient was 33. 3c, water was 42c and flow was 2lpm. Rewarm was from 36. 0c at 0. 25c/hr to 36c and there was adequate coverage. Ms&s adjusted rewarm from to current patient temperature. Ms&s asked nurse to be diligent with skin checks. Nurse confirmed she could add other warming measures. The device responding appropriately.

• 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: 10011623
• MDR Text Key: 189709382
• Report Number: 1018233-2020-02935
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/29/2020
• 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: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse