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

Model Number 50000000L

Device Problem Insufficient Cooling (1130)

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

Event Date 02/10/2022

Event Type  malfunction  

Event Description

It was reported that the biomed heard chattering noise from circulation pump of the arctic sun device. Biomed dissembled pump from motor and observed that the bearing showed signs of seizing when shaft was spun by hand. Biomed performed visual inspection and determined that the ac cca card and power module had degraded due to electrical overstress and would be replaced preventatively. Per procedure, the control panel coin cell battery had reached an age of or beyond 2 years old and required replacement. It was also stated that the arctic sun device failed the chiller efficiency test.

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 5000
• 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: 13696238
• MDR Text Key: 287005293
• Report Number: 1018233-2022-01157
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000L
• Device Catalogue Number: 50000000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 03/08/2022 Patient Sequence Number: 1