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

Model Number 8001

Device Problem Excessive Cooling (2932)

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

Event Date 11/23/2022

Event Type  malfunction  

Event Description

It was reported that the altrix overshot the target temperature of 36° c and is currently reading 34° c, with a water temperature of 40° c and altrix in auto.The patient was not injured and no clinically relevant delay in therapy was reported during this event.

Manufacturer Narrative

The patient temperature was checked with a second source.Upon doing this the rn discovered the secondary temperature probe had become detached from the patient.From this information, and a review of the data from this altrix unit.It was determined that this event was not due to any component level malfunction with the unit and likely due to user error.The manufacturing date for this unit has been corrected.

Event Description

It was reported that the altrix overshot the target temperature of 36° c and is currently reading 34° c , with a water temperature of 40° c and altrix in auto.The patient was not injured and no clinically relevant delay in therapy was reported during this event.

• 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: 15971130
• MDR Text Key: 305377962
• Report Number: 0001831750-2022-01228
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 11/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/07/2019
• 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