MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN® 5000; SYSTEM, THERMAL REGULATING

Model Number 5000

Device Problems Display or Visual Feedback Problem (1184); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2022

Event Type  malfunction  

Event Description

Arctic sun therapy was initiated in the early am.Water temperature appeared at a high value (~85f) without a warning.Icu charge nurse called to bedside for assistance.Device was troubleshooted from help menu.Soon after, emergency help line number called.Upon receiving a call-back from the helpline, troubleshooting was conducted per instruction.Error code 113 appeared & it was discovered that the device was malfunctioning.Device was stopped immediately.The device was replaced, and cooling was reinitiated a little over an hour later.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 16378199
• MDR Text Key: 309561573
• Report Number: 16378199
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/02/2023,10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA