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

Model Number 50000000L

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2018

Event Type  malfunction  

Event Description

While in use the arctic sun equipment used for cooling started smoking.A new machine was obtained.There was no harm.

• Brand Name: ARCTIC SUN 5000
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 321 south taylor ave suite 200; louisville CO 80027
• MDR Report Key: 7788534
• MDR Text Key: 117283609
• Report Number: 7788534
• 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: 08/09/2018,08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000L
• Device Catalogue Number: 50000000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 90