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

Catalog Number 60000000

Device Problem Failure to Power Up (1476)

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

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that nurse stated they tried to kept patient normothermic at 37c.The patient temperature when they initiated therapy was above 37c.The patient temperature has since dropped below target, the lowest was 35.5c.Nurse stated they did increase the targeted temperature to 37.5c to help keep the patient closer to target.Confirmed they had adequate pad coverage, no shivering noted.Water temperature (wt) was 31c and dropped to 29c, water flow rate (wfr) was 2.4 l/min.Confirmed no other therapies in progress, no recent medication administration.Walked nurse through placing device in manual control, after a few minutes water temperature still 30c.Nurse stated the device shut off when they first started therapy and when they turned it back on, it alarmed the reservoir was empty so they added water.They had not emptied the pads.Nurse stated the device was plugged into the bed at the time, they moved it to a wall outlet.Explained recommend using a grounded wall outlet as the bed was not enough to power the device.Explained whenever the device turns off without emptying the pads first, the device cannot sense the water in the pads and this risks overfilling.Walked nurse through draining 500 ml of water from right drain port only.After a few minutes, water temperature was 37.5c.Had nurse disable manual control.Nurse adjusted targeted temperature back to 37c and resumed therapy.

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: 18825288
• MDR Text Key: 337690685
• Report Number: 1018233-2024-01094
• 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: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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: 02/08/2024
• 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