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

Model Number 50000000

Device Problem Insufficient Information (3190)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that neonatal intensive care unit nurse stated that they had issues with another device so they swapped out pads and were on a different device now.Nurse wanted to verify device was working correctly.The patient temperature was 32.1c, target temperature was 33.5c, water temperature was 36.8c and water flow rate was 0.8 l/m.Patient started on this device about 20 to 30 minutes.Mis advised that the device appears to be working appropriately.Nurse confirmed esophageal probe placement was verified.Mis discussed patient medications.Mis encouraged nurse to add rolled blankets to the sides of the baby to "taco" them in for better coverage.Mis discussed utilizing overhead warmer per their protocol to assist with patient temperature.

Manufacturer Narrative

As per review, bd has determined that this mdr event is not reportable.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that neonatal intensive care unit nurse stated that they had issues with another device so they swapped out pads and were on a different device now.Nurse wanted to verify device was working correctly.The patient temperature was 32.1c, target temperature was 33.5c, water temperature was 36.8c and water flow rate was 0.8 l/m.Patient started on this device about 20 to 30 minutes.Mis advised that the device appears to be working appropriately.Nurse confirmed esophageal probe placement was verified.Mis discussed patient medications.Mis encouraged nurse to add rolled blankets to the sides of the baby to "taco" them in for better coverage.Mis discussed utilizing overhead warmer per their protocol to assist with patient temperature.As per follow up information received via email on (b)(6), 2023, it was reported that therapy was completed and there was no impact to the patient.The patient was a baby but identifying information could not be remembered at this time.The charge nurse stated that the 'taco' was used.The device did not go to biomed.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16955049
• MDR Text Key: 315552005
• Report Number: 1018233-2023-03574
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2023
• 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 Sequence Number: 1
• Patient Outcome(s): Other