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

Catalog Number	8001000001
Medical Device Problem Code	Excessive Cooling (2932)
Health Effect - Clinical Code	Chills (2191)
Date of Event	10/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had a goal temperature of 33.5 but patient temperature was 30.7.It was further reported that the baby was overcooled by 2.8 degrees and the baby was shivering.
Additional Manufacturer Narrative
There were no rfu codes or an alleged malfunction of the device.Based on the information provided, it was determined that this event was likely not due to a component level malfunction and instead due to the therapy selection.The user should not have switch the warming therapy as the device would have corrected for the slight overshoot.Switching therapy modes prolonged the issue and likely contributed to the alleged event.This issue was resolved for the customer by instructing the user to use max warming.
Event or Problem Description
It was reported that the device had a goal temperature of 33.5 but patient temperature was 30.7.It was further reported that the baby was overcooled by 2.8 degrees and the baby was shivering.No adverse consequences or serious injury were reported for this event.

• 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: 20734311
• Report Number: 0001831750-2024-01401
• Device Sequence Number: 8499689
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: (01)07613327277555
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/01/2025

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: 10/27/2024
• Supplement Date Received by Manufacturer: 10/27/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2019
• 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