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

Catalog Number 8001000001

Device Problems Insufficient Cooling (1130); Insufficient Heating (1287)

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

Event Date 03/31/2024

Event Type  malfunction  

Event Description

It was reported that the patient is warming but the temperature is slowly decreasing.The target temperature is 36.5, patient temperature is 33.9, the patient temperature was 34.4.The patient is an infant in an isolate.A delay in warming time was reported, however no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the target temperature is 36, the patient temperature is 36.6.The nurse gave a medication to the patient due to the patient shivering and now the patient temperature is 37.5 for 45mins.The water temperature is 28, and no alarms.The nurse practioner noticed a difference since they switched to the torso/leg wraps instead of a blanket.It was reported that the patient does have a neuro diagnosis.No adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Corrected the event description in section b5, corrected the serial number in section d4, and corrected the manufacturing date in section h4.

• 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: 19117912
• MDR Text Key: 340611311
• Report Number: 0001831750-2024-00364
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 03/31/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2021
• 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