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

Model Number 8001

Device Problem Insufficient Cooling (1130)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

It was reported that during therapy, blanket/wrap contact surface temperature not cold enough.There was patient involvement, but no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was reported that the trial altrix unit did not cool as expected (blanket/wrap contact surface temperature not cold enough).Upon completion of the investigation, it was identified that this issue was the result of user error.It was found that the device had no defect, and the alleged complaint could not be recreated or duplicated.No parts were replaced, and the unit was returned to service.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.Per 21 cfr 820 this does not meet the definition of a reportable complaint.

Event Description

It was originally reported that during therapy, blanket/wrap contact surface temperature not cold enough.There was patient involvement, but no adverse consequence or clinically relevant delay in treatment was reported.Upon completion of the investigation, it was identified that this issue was the result of user error.It was found that the device had no defect, and the alleged complaint could not be recreated or duplicated.No parts were replaced, and the unit was returned to service.No patient was affected and no adverse consequence or 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: melissa millard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13966794
• MDR Text Key: 288320540
• Report Number: 0001831750-2022-00278
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• 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
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2020
• 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