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

Catalog Number 8001000001

Device Problem Insufficient Information (3190)

Patient Problem Alteration In Body Temperature (2682)

Event Date 07/21/2017

Event Type  malfunction  

Event Description

It was reported that the user facility was experiencing patient temperature deviation issues.

Manufacturer Narrative

There were no adverse consequences reported to the patient experiencing temperature deviation.The user facility was provided feedback on proper device operation.

Event Description

It was reported that the user facility was experiencing patient temperature deviation issues.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was reported that the user facility was experiencing patient temperature deviation issues.

• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6800331
• MDR Text Key: 83098079
• Report Number: 0001831750-2017-00332
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/29/2018

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 Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 07/21/2017; 07/21/2017
• Supplement Dates FDA Received: 09/27/2017; 03/29/2018
• Was Device Evaluated by Manufacturer?: No
• 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