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

Model Number 50000000

Device Problem Overheating of Device (1437)

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

Event Date 08/11/2021

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 device was having issues with the mixing pump and would be coming in for the 2000 hour preventive maintenance service. Per medwatch report received on 04feb2021, it was reported that the cooling device failed. When arctic sun device was placed, it showed error 113 (reduced water temperature control). The device was later pulled out of service and tested by biomedical department who noted error 80 (non-recoverable system error) which meant the control processor failed to detect a simulated water temperature fault. Biomed later contacted the vendor who reported that the mixing pump was not working correctly and was not pushing enough cold water into the lines to cool the patient to the correct temperature and the vendor noted that the pump had to be replaced. The unit was then sent to the vendor for repair. It was also reported by biomed that there was another unit with the same issue and this was also sent for repair. It was further stated that the units had appropriate preventive maintenance. Per sample evaluation, it was reported that the control panel was frozen and unresponsive to touch. The main voltage circuit card electrical terminal and power inlet module showed signs of electrical stress.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• 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: 12417656
• MDR Text Key: 269831769
• Report Number: 1018233-2021-05386
• 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
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/11/2021
• 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: 09/02/2021 Patient Sequence Number: 1