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

Model Number 8001

Device Problem Excessive Heating (4030)

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

Event Date 09/15/2020

Event Type  malfunction  

Event Description

It was reported that the temperature deviation alarm occurred after the patient had been on for 9 hours.It was reported that the machine was functioning well and then the patient temperature increased to 36.6 with a goal temperature on auto at 36.The water temperature was cooler than the patient when the patient temperature started to come down.Once the patient temperature was at 36.5 the alarm turned off.The patient was not adversely affected and no clinically relevant delay in treatment was reported.

Manufacturer Narrative

The product met specifications at the time of evaluation as no component level defect was found with the product and the unit worked to specification.

Event Description

It was reported that the temperature deviation alarm occurred after the patient had been on for 9 hours.It was reported that the machine was functioning well and then the patient temperature increased to 36.6 with a goal temperature on auto at 36.The water temperature was cooler than the patient when the patient temperature started to come down.Once the patient temperature was at 36.5 the alarm turned off.The patient was not adversely affected and no clinically relevant delay in treatment was reported.

• Brand Name: ALTRIX, DOMESTIC
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10635624
• MDR Text Key: 210011261
• Report Number: 0001831750-2020-00924
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: 07613327277555
• Combination Product (y/n): N
• PMA/PMN Number: K152266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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 Operator: No Information
• Device Model Number: 8001
• Device Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1