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

Model Number 50000000

Device Problems Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Effects, Unexpected (2099); No Consequences Or Impact To Patient (2199)

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 above target while on the arcticsun device. The target was 36c, and the patient was 36. 7c. The nurse stated demerol was administered with no change in the patients temperature. The trend was neutral. She decreased the temperature in the patients room, and alternated using a bair hugger. She stated the patient had experienced a cerebrovascular accident prior to being on the device, but there was no patient shivering, the jaw was relaxed, and no signs of a seizure or infection. The patients temperature was 36. 5c, the water temperature was 14. 9c, and the flow rate was 3. 1l/min. The nurse was advised the device was working as expected.

• Brand Name: ARCTICSUN 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: 9371553
• MDR Text Key: 178123573
• Report Number: 1018233-2019-07529
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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

• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

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: 01/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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: 11/25/2019 Patient Sequence Number: 1