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

Model Number 50000000E

Device Problems Device Alarm System (1012); Insufficient Cooling (1130)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2021

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 nurse had gone through three arctic sun devices. The patient was not currently on a device, and they switched to stryker cooling blankets and ice packs and were wondering about getting a loaner device. The first arctic sun device was alarmed and advised to take the device out of the service. It was also reported that the first arctic sun device switched out to a second device that worked fine all night, but then after ct (computed tomography) scan the device was not cooling, so it was switched out and the complainant just took off the third device because the water temperature was going up instead of going down to cool the patient. The patient temperature was 98. 6 f. The complainant had tried adding the water and other troubleshooting method¿s, but nothing seemed to work. Ms&s advised the nurse since the device was not in use, it would be difficult to troubleshoot and asked to send the devices to biomed for further investigation. Ms&s also explained that adding water to the device should not be a part of troubleshooting as this could lead to a malfunctioning of the heater. They called earlier on the same day and stated that the second device was not cooling and received an alert 113. The patient was currently 34. 7 c and the water temperature was 37 c. The water temperature was 88. 1 f (31. 2 c). The target temperature was 91 f (32. 3 c). The patient temperature was 96 f (35. 6 c). There was a good flow. There were multiple alerts of 113. It was noted that nothing was blocked in the vents and mo other devices were available in the ccu (critical care unit) or nicu (neonatal intensive care unit).

• 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: 11263523
• MDR Text Key: 229812490
• Report Number: 1018233-2021-00222
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• 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: 08/10/2021
• 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

Patient Treatment Data

Date Received: 02/01/2021 Patient Sequence Number: 1