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

Model Number 50000000

Device Problems Insufficient Cooling (1130); Display or Visual Feedback Problem (1184); Inadequacy of Device Shape and/or Size (1583)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the arctic sun device was insufficiently cooling. The device was placed into manual control and the system diagnostics displayed the system hours 4786, pump hours 4316, t1 was 6. 2 c, t2 was 6. 3 c, and t4 was 4. 3 c. Mss advised that the device was making cold water and that the pads may be improperly sized for the patient. Per follow up, the patient was switched to an alternate device and was able to reach target and complete therapy. The device was sent to biomed where it passed a functional check and was placed back into service.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTICSUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8547200
• MDR Text Key: 144531614
• Report Number: 1018233-2019-02151
• 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: health professional,other,use

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse