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	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient temperature has been staying between 36.2-36.4.The water temperature is 40 set to max/auto, target temperature is 36.5, with an esophageal probe at 36.2 and ax temperature of 36.4.The patient was not adversely consequence and no clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
There were no alarms or reported patient injuries, as the unit delivered the intended warming temperature.The patient's temperature measurement was accurate within 0.3°c, suggesting the unit functioned correctly.Based on this, a stryker sr quality assurance engineer concluded that the reported issue with the device was unlikely due to a component malfunction.No further troubleshooting or action was required from stryker.
Event or Problem Description
No new information.

• 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: 21277570
• Report Number: 0001831750-2025-00316
• Device Sequence Number: 9529408
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: (01)07613327277555
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: 01/03/2025
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2023
• 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