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

Model Number 50000000

Device Problem Computer Operating System Problem (2898)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It was reported that the arctic sun device had been cooling from (b)(6) 2021 at 3:30 pm. Nurse stated that the device was displaying alarm 64 (non-recoverable system error) and unable to enable the pump power (control processor) and the device got stopped. Mss cycled the power and restarted the therapy. The patient temperature was 33. 7c, target temperature was 33c and water temperature was 19c dropped to 12. 6c. The bladder probe was in place. Mss recommended to change out the device if the alarm reoccurred. Also discussed about the heat generation and encouraged to follow their drug protocol if the patient did not drop. Nurse reported that the device was off for about 30 minutes.

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.

• 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: 13031158
• MDR Text Key: 282501924
• Report Number: 1018233-2021-08185
• 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: Other,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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
• Date Manufacturer Received: 12/02/2021
• 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

Patient Treatment Data

Date Received: 12/17/2021 Patient Sequence Number: 1