MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE

Device Problem Failure to Sense (1559)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

It was reported that the nurse starting therapy on a patient, but the arctic sun device was alarming 14 patient temperature1 probe was out of range.Nurse stated that they had an esophageal probe and a foley probe, however they did not think the foley probe was working.The esophageal probe was 36.4c on the bedside monitor.Confirmed with nurse they had the grey temperature cable plugged into the patient temperature (pt)1 port on the back of the device, cable was secure.Confirmed when they plug the esophageal probe into the arctic sun temperature cable, the temperature did not display on the screen.Informed nurse they would recommend try a new temperature cable.If they had another device, they could swap the cables out, nurse stated that they did not have another device.Suggested to check with biomed to see if they had an extra cable in the shop.Biomed at bedside, stated that they did not have any additional cables.Informed nurse the patient temperature probe must be plugged into the patient temperature in order to drive therapy, without this working they would not be able to perform therapy on this device.Recommended they consider an alternative means of cooling.Nurse disconnected before being able to get device.Nurse manager stated that they recently called, they had a device with a bad temperature in cable.Nurse stated that they had an extra temperature in cable in office and they were able to swap it out and start therapy and asked if they could order another temperature in cable to have on hand.Emailed the ttm temperature cables to identify which temperature in cable they have.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is a failed temperature in cable.A dhr review is not required as the serial number is unknown.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.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® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• Type of Device: TEMPERATURE MANAGEMENT SYSTEM
• 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: 17975173
• MDR Text Key: 326320553
• Report Number: 1018233-2023-07607
• 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: Physician
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• 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