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

Catalog Number	8001000001
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged that a patient was burned while using the altrix.Severity and treatment information have not been provided at the time of reporting.
Additional Manufacturer Narrative
Additional details were provided regarding the alleged injury.The burn occurred in the operating room and was treated with silvadene cream.A clinical nurse consultant employed by stryker reviewed therapy data from the unit and did not find any abnormal temperature output from the unit.The unit was evaluated by stryker field service and no defect was found with the unit.A stryker medical science liaison identified that the combination of positioning during that surgery and comorbidities from that diagnosis likely reduced blood flow to the patient's skin, which would have made the patient more susceptible to burns.Based on this information, it was concluded that the burns were not attributed to the altrix device as the device did not pose a hazard or exhibit a malfunction.
Event or Problem Description
It was alleged that a patient was burned while using the altrix.Severity and treatment information have not been provided at the time of reporting.

• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 20302974
• Report Number: 0001831750-2024-01074
• Device Sequence Number: 15401709
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: (01)07613327277555(21)2024000100635
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K180834
• 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): 01/31/2025

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: 08/26/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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