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

Model Number 8001

Device Problems Insufficient Cooling (1130); Insufficient Heating (1287)

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

Event Date 09/23/2022

Event Type  malfunction  

Event Description

It was reported by the customer that they had an issue with the last therapy they did with achieving target temperature.The patient was not adversely affected and no clinically relevant delay in treatment was reported.

Manufacturer Narrative

A data pull from the device identified that the issue was due to user error.

Event Description

It was reported by the customer that they had an issue with the last therapy they did with achieving target temperature.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: 15628714
• MDR Text Key: 304803399
• Report Number: 0001831750-2022-00935
• 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: 12/09/2022

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 Model Number: 8001
• Device Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• 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