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 11/29/2022

Event Type  malfunction  

Event Description

It was reported that a patient was over cooled by 2.5° c.No alarms went off on the altrix, goal temperature was 33° c, patient was 30.5° c, blanket noted to be cool to touch despite settings placed to rewarm due to over cooling.No adverse consequences or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The customer stated that they found that there were kinks in the blanket by the connection to the hose.Flow and heating/cooling resumed normally after removal of the kinks.

Event Description

It was reported that a patient was over cooled by 2.5° c.No alarms went off on the altrix, goal temperature was 33° c, patient was 30.5° c, blanket noted to be cool to touch despite settings placed to rewarm due to over cooling.No adverse consequences 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 15971007
• MDR Text Key: 305378016
• Report Number: 0001831750-2022-01229
• 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: 02/06/2023

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: 11/29/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2018
• 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