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

Model Number 50000000

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Sensing Problem (2917); Temperature Problem (3022)

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. The device was not returned.

Event Description

It was reported that the water temperature had been stable around 36. 1c during normothermia therapy on the arctic sun device, but then suddenly spiked to 41. 6c. The water temperature then went back down, so they changed devices. The second device did the same thing. There was a foley probe in use. Per troubleshooting with ms&s, the nurse denied there being any alerts/alarms but was not in the room at the time to look at the event log. Ms&s suggested troubleshooting the foley probe if the temperature becomes erratic again. They had changed the pads previously that day to size medium. The pads were too small, so a universal pad was added. Ms&s explained this should not cause a sudden change in water temperature. Per additional information received via phone on (b)(6) 2019 with the biomed technician, the first device was received in biomed where it was ran for several hours with a temp probe and pads. He stated that he also placed the device in manual mode to confirm functionality and found no issues with the device. The temperatures did not read erratic during his evaluation.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN 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: 8514510
• MDR Text Key: 142611843
• Report Number: 1018233-2019-01951
• 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: 05/31/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/15/2019
• 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: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse