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

Model Number 8001

Device Problems Insufficient Cooling (1130); Excessive Heating (4030)

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

Event Date 06/17/2023

Event Type  malfunction  

Event Description

It was reported that the device had to be switched out due to a patient temperature deviation alarm occurring during therapy.It was reported that the device was set to auto mode and used with a foley/bladder temperature probe connected to the device.A secondary temperature was confirmed and correlating.The goal temperature was 98.6f, with a current patient temperature of 100.2f, and current water temperature of 59.4f.The patient was not harmed during this event.

Manufacturer Narrative

The customer was advised to try a new temperature probe, unplug device for ten seconds and restart the unit.The customer did not confirm if this resolved the issue.H3 other text: evaluation was not requested.

Event Description

It was reported that the device had to be switched out due to a patient temperature deviation alarm occurring during therapy.It was reported that the device was set to auto mode and used with a foley/bladder temperature probe connected to the device.A secondary temperature was confirmed and correlating.The goal temperature was 98.6f, with a current patient temperature of 100.2f, and current water temperature of 59.4f.The patient was not harmed 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: 17184186
• MDR Text Key: 317920896
• Report Number: 0001831750-2023-00672
• 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
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

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?: Yes
• Initial Date Manufacturer Received: 06/17/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 06/17/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2018
• 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