MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ALTRIX, DOMESTIC; SYSTEM, THERMAL REGULATING

Catalog Number	8001000001
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an rn called from the nicu about a patient temperature being lower then goal temperature.It was reported that they were using auto mode with an esophageal probe and were unable to verify with secondary temperature due to the temperature being very low.The goal temperature was 33.5 which was reached in the am.Then during night shift the temperature started decreasing down to 31.The current water temperature is between 38 - 41.2.No alarms were beeping and the hoses and wrap feel warm to touch.
Event or Problem Description
It was reported that an rn called from the nicu about a patient temperature being lower then goal temperature.It was reported that they were using auto mode with an esophageal probe and were unable to verify with secondary temperature due to the temperature being very low.The goal temperature was 33.5 which was reached in the am.Then during night shift the temperature started decreasing down to 31.The current water temperature is between 38 - 41.2.No alarms were beeping and the hoses and wrap feel warm to touch.
Additional Manufacturer Narrative
It was found that the cause behind the drop in the temperature could not be determined.The support line nurse verified that the altrix was working correctly and suggested that the issue maybe with the patient.This issue was resolved for the customer by verifying that no further action needed from the stryker.

• Brand Name: ALTRIX, DOMESTIC
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 20034461
• Report Number: 0001831750-2024-01061
• Device Sequence Number: 3035590
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: 07613327277555
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown