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	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the temperature deviation alarm was occurring.The device was in manual mode with a goal patient temperature of 98.0 and a current patient temperature of 100.The current water temperature is 80.8, with a water temperature goal of 55.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
A review of information provided identified that this event was likely due to a flow obstruction created by a user setup error.
Event or Problem Description
It was reported that the temperature deviation alarm was occurring.The device was in manual mode with a goal patient temperature of 98.0 and a current patient temperature of 100.The current water temperature is 80.8, with a water temperature goal of 55.The patient was not adversely affected and no clinically relevant delay in treatment was reported.

• 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: 19877100
• Report Number: 0001831750-2024-01052
• Device Sequence Number: 12576184
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2018
• 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