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

Catalog Number	8001000001
Medical Device Problem Codes	Insufficient Cooling (1130); Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the altrix had been switched from cooling to warming and the patient temperature decreased.The altrix was set to auto/max, patient 35.9, water 40, target 37, second temp 35.5.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Based on information gathered during the investigation.A sr quality assurance engineer determined that the alleged device issue was likely not due to a component level malfunction as adjusting the therapy settings resolved the alleged issue.This issue was resolved for the customer by changing the therapy mode to automatic maximum cooling.

• 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: 20978105
• Report Number: 0001831750-2024-01411
• Device Sequence Number: 20923210
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: (01)07613327277555
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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