MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM; SYSTEM, THERMAL REGULATING

Device Problems Break (1069); Temperature Problem (3022)

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

Event Date 11/16/2022

Event Type  malfunction  

Event Description

At 0030, artic sun tech support called for temperature issues with warmer water temp and temp probes above target temperature.Rectal probe is now onto temp probe #1, ad swapped with esophageal probe.2nd machine in house with broken temp probe.At 0430, artic sun tech support called for water temperature fluctuating.Advised to swap cable in back of machine from #2 spot to #1 and attach to rectal probe.Next day, at 515, water temp continued to decline to temp 11.5 c.Artic sun turned off and new artic sun machine replaced around 0535.New parameters adjusted.Rectal probe attached to #1.Remaining time left as of 0522 is 65 hrs of cooling time.Heart rate dipped into low 80's.Md aware of machine issues.This machine was checked by biomed less than 1 month ago and reported that it was "functioning as it should".They are currently working to check both of our in-house machines.Our rental company does not carry this type of cooling machine and we do not have disposables to use any of their equipment as backup.3rd machine obtained by house.Machine functioning properly as we are into day 2 of cooling protocol.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 321 south taylor avenue; suite 200; louisville CO 80027
• MDR Report Key: 16938687
• MDR Text Key: 315297358
• Report Number: 16938687
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023,02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: Black Or African American