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

Catalog Number 8001000001

Device Problem Insufficient Cooling (1130)

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

Event Date 03/31/2024

Event Type  malfunction  

Event Description

It was reported that, during therapy, the contact surface would not reach sufficient coolness and that this caused a delay in therapy for the patient.No other adverse consequences were alleged to have occurred as a result.

• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19192993
• MDR Text Key: 341423173
• Report Number: 0001831750-2024-00688
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/26/2024

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 Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2022
• 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