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

Catalog Number 60000000

Device Problem Lack of Effect (4065)

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

Event Date 03/28/2024

Event Type  malfunction  

Event Description

It was reported that targeted temperature (tt) was 36c, but patient had been at 36.7c for a while.They wanted to make sure they were not missing anything.Water temperature (wt) was 12.9c, flow rate was 2.3lpm.Patient needed medium pads, but they only had large, they were overlapped in the back, low water limit 4c, mixing pump command was 25%.Alarm 104 (manual control end) and 112 (confirm return to cooling phase) in event log.Patient arrived 35c and was not to 36c after several hours, so they put the device in manual control with a water target of 40c.When the patient reached 36c they changed back to automatic mode.Explained that if this comes up again in the future, they did not need to place the device in manual.If the target was higher than the patient's current temperature the water temperature would increase on its own to increase patient temperature.Patient was unstable, and prone.They were unable to check pad coverage on the front.The patient was too unstable to give tylenol.No signs of shivering or seizure, they would start eeg tomorrow.Device responding appropriately suggested treating heat generation per facility protocol.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

• Brand Name: ARCTIC SUN STAT
• 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: 19106434
• MDR Text Key: 340905687
• Report Number: 1018233-2024-02065
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200225
• 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
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• 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