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

Model Number 8001

Device Problems Excessive Cooling (2932); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

It was reported that patient was cooled to 33°c and the order was for 36°c.There was no report of patient adverse consequence or clinically relevant delay in treatment.

Manufacturer Narrative

It was reported that the device was set to the incorrect temperature of 33 degrees by a nurse and the nurse was inquiring through the device help line to understand the appropriate amount of time for the device to adjust to the correct temperature of 36 degrees.The user was educated that the altrix will warm the patient to the set temperature and that the rate at which the warming occurs can be increased as needed.Through communication with the user facility it was identified that this was a customer inquiry on device operation and no defect or malfunction was alleged with the device.The patient was not adversely effected during this event.H3 other text : no alleged device malfunction.

Event Description

It was originally reported that patient was cooled to 33°c and the order was for 36°c.It was identified that this was a customer inquiry on how the device will adjust the temperature when set correctly.There was no report of patient adverse consequence or clinically relevant delay in treatment.

• 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: 17219617
• MDR Text Key: 318051803
• Report Number: 0001831750-2023-00677
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• 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: 06/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2022
• 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