MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ALTRIX, 120V/60HZ, TYPE B; SYSTEM, THERMAL REGULATING

Catalog Number 8001000003

Device Problems Excessive Cooling (2932); Excessive Heating (4030)

Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)

Event Date 09/08/2019

Event Type  malfunction  

Event Description

It was reported that the patient was overcooled, device temperature was set to 35°c and the patient temperature was 28°c.It was then reported that the patient overheated during rewarming, device temperature set at 36°c and the patient temperature went to 38.3°c.No adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

This issue was resolved for the customer by confirming proper therapy functionality.

Event Description

It was reported that the patient was overcooled, device temperature was set to 35°c and the patient temperature was 28°c.It was then reported that the patient overheated during rewarming, device temperature set at 36°c and the patient temperature went to 38.3°c.No adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: ALTRIX, 120V/60HZ, TYPE B
• 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: 9153642
• MDR Text Key: 168815531
• Report Number: 0001831750-2019-00919
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8001000003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2018
• 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