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

Catalog Number	8001000001
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was not cooling.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.The device is currently pending repair.
Event or Problem Description
It was reported that the device was not cooling.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
The device has not been evaluated.This issue was resolved for the customer by replacing the thermal unit under the service report when the part is available.

• Brand Name: ALTRIX, DOMESTIC
• Common Device Name: 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19666438
• Report Number: 0001831750-2024-00730
• Device Sequence Number: 6904805
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: (01)07613327277555(21)2023000100097
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K152266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown