MAUDE Adverse Event Report: C.R. BARD, INC. ARCTIC SUN 5000; THERMAL REGULATION SYSTEM

Model Number ARCTIC SUN 5000

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2017

Event Type  malfunction  

Event Description

Bard sent an urgent message through the emergency care research institute (ecri) about components of their device that are failing at 2000 hours.Bard is proposing a preventative maintenance (pm) program to replace these components that will cost the organization fees to do.The original service manual and pm program does not indicate anything related to such components.We feel this new requested change should not be for any charge or fees to the organization, as it has never been identified as part of any pm before.

• Brand Name: ARCTIC SUN 5000
• Type of Device: THERMAL REGULATION SYSTEM
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 6710037
• MDR Text Key: 79921392
• Report Number: 6710037
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARCTIC SUN 5000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2017
• Device Age: 2 YR
• Date Report to Manufacturer: 07/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1