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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient cooled 2 degrees celsius under target temperature with no patient temperature deviation alarms from the device.The goal temperature is 33.5 degrees, patient temperature is 31.6 degrees per esophageal probe connected to altrix device.Therapy started at 0445 am, patient starting temperature was 36 degrees.Current water temperature is 29.1 degrees.Noted on 90 minute graph water temperature 25-29 degrees, and frequent deviations of patient temperature.
Additional Manufacturer Narrative
Based on on the information provided, there was likely no issue with the product as the issue was able to be resolved by the customer.There was no alleged patient harm as a result of the patient temperature overshoot.This issue was resolved for the customer by confirming no further action was needed to resolve the issue.The udi number and manufacturing dated have been corrected.
Event or Problem Description
It was reported that the patient cooled 2 degrees celsius under target temperature with no patient temperature deviation alarms from the device.The goal temperature is 33.5 degrees, patient temperature is 31.6 degrees per esophageal probe connected to altrix device.Therapy started at 0445 am, patient starting temperature was 36 degrees.Current water temperature is 29.1 degrees.Noted on 90 minute graph water temperature 25-29 degrees, and frequent deviations of patient temperature.

• 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: 19933116
• Report Number: 0001831750-2024-01055
• Device Sequence Number: 11474800
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: (01)07613327277555(21)2019000100710
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2019
• 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