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.

• 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: 10635624
• MDR Text Key: 210011261
• Report Number: 0001831750-2020-00924
• Device Sequence Number: 1
• Product Code: DWJ
• 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

• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8001
• Device Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse