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

Catalog Number 60000000

Device Problem Power Problem (3010)

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

Event Date 03/01/2024

Event Type  malfunction  

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.

Event Description

It was reported that they had a patient being treated on arctic sun device.The target temperature was set to 36c, but the patient temperature was 34.7c.They have restarted and reprogrammed the device, but the patient temperature was still at 34.7c.Target temperature was 36c, in hypothermia.Patient temperature was 34.7c.Flow rate was 3.4lpm.Water temperature was 27.8c.Event log shows alarms 50 (patient temperature 1 erratic), 45 (ac power lost), 5 (water reservoir empty), and 116 (patient temperature not changed).Water level 5.Heater command 100 percentage.Nurse confirms filling reservoir when they got alarm 5.Walked nurse through draining excess water from circulation tank.Water up to 30.6c and increasing.

Event Description

It was reported that they had a patient being treated on arctic sun device.The target temperature was set to 36c, but the patient temperature was 34.7c.They have restarted and reprogrammed the device, but the patient temperature was still at 34.7c.Target temperature was 36c, in hypothermia.Patient temperature was 34.7c.Flow rate was 3.4lpm.Water temperature was 27.8c.Event log shows alarms 50 (patient temperature 1 erratic), 45 (ac power lost), 5 (water reservoir empty), and 116 (patient temperature not changed).Water level 5.Heater command 100 percentage.Nurse confirms filling reservoir when they got alarm 5.Walked nurse through draining excess water from circulation tank.Water up to 30.6c and increasing.

Manufacturer Narrative

The reported issue was inconclusive.The root cause of the reported issue could not be identified.Although a root cause could not be definitively identified, a potential root cause for this type of failure could be device not plugged into medical grade outlet.However, there was insufficient information to confirm this potential root cause.A dhr is not required as this is event not an out-of-box failure and therefore is not manufacturing related.The instructions for use were found adequate and state the following: "power cord has a hospital grade plug.Grounding reliability can only be achieved when connected to an equivalent receptacle marked ¿hospital use¿ or ¿hospital grade.¿ 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: 18939759
• MDR Text Key: 338113442
• Report Number: 1018233-2024-01459
• 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,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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