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

Model Number 8001

Device Problem Excessive Cooling (2932)

Patient Problem Alteration in Body Temperature (4568)

Event Date 12/19/2021

Event Type  malfunction  

Event Description

It was reported the patient was being cooled to a target temp of 36 degrees but the device overshot the temperature and cooled the patient to 35.1 degrees.The device alarmed and began warming the patient back up to target temperature.There are no reports of adverse consequences as a result of this event.

Manufacturer Narrative

This issue was resolved for the customer by explaining the alarm settings of the device.

Event Description

It was reported the patient was being cooled to a target temp of 36 degrees but the device overshot the temperature and cooled the patient to 35.1 degrees.The device alarmed and began warming the patient back up to target temperature.There are no reports of adverse consequences as a result of this event.

• Brand Name: ALTRIX, DOMESTIC
• Type of Device: 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: 13054398
• MDR Text Key: 282626588
• Report Number: 0001831750-2021-01658
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: 07613327277555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8001
• Device Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1