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

Model Number 50000000E

Device Problem Intermittent Loss of Power (4016)

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

Event Date 02/02/2022

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 got low water alert 03 (water reservoir low), so the device was filled. Nurse called because water temperature was higher that it had been and it was in the 20s. Nurse stated that the event log showed alert 114 (treatment stopped), alert 112(confirm return to cooling phase), and alert 03 (water reservoir low). Nurse stated that current water temperature was 35. 9c, target temperature was 35. 5c, patient temperature was 33. 2c and neonate pad flow rate was 1. 6 l/m. Mss told the nurse to do nothing since patient was at goal and to call back if needed. Per follow up information received via phone on 02feb2022, nurse stated that the therapy was completed with no impact to the patient because baby was at goal temperature. Nurse stated that the arctic sun device continued to shut down on its own and was not functioning properly. Nurse stated that the arctic sun device was not sent to the biomed.

Event Description

It was reported that the arctic sun device got low water alert 03 (water reservoir low), so the device was filled. Nurse called because water temperature was higher that it had been and it was in the 20s. Nurse stated that the event log showed alert 114 (treatment stopped), alert 112(confirm return to cooling phase), and alert 03 (water reservoir low). Nurse stated that current water temperature was 35. 9c, target temperature was 35. 5c, patient temperature was 33. 2c and neonate pad flow rate was 1. 6 l/m. Mss told the nurse to do nothing since patient was at goal and to call back if needed. Per follow up information received via phone on 02feb2022, nurse stated that the therapy was completed with no impact to the patient because baby was at goal temperature. Nurse stated that the arctic sun device continued to shut down on its own and was not functioning properly. Nurse stated that the arctic sun device was not sent to the biomed.

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 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: 13590661
• MDR Text Key: 286055280
• Report Number: 1018233-2022-00838
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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
• Date Manufacturer Received: 02/02/2022
• 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: 02/24/2022 Patient Sequence Number: 1