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

Catalog Number 8001000001

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 07/08/2018

Event Type  malfunction  

Event Description

It was reported that the target temperature was set at 33°c and the patient overshot the temperature to 31.8°c.Upon attempting to rewarm later, they had difficulty rewarming.

Manufacturer Narrative

For the issue of the patient temperature deviations (both cooling and re-warming), the user was advised to adjust the machine to automatic mode to better control the patient temperature to the desired target.The user was informed that they may call back if any issues persist.The customer did not call back, indicating that no further action is needed at this time.

Event Description

It was reported that the target temperature was set at 33°c and the patient overshot the temperature to 31.8°c.Upon attempting to rewarm later, they had difficulty rewarming.

• 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: 7752850
• MDR Text Key: 116308866
• Report Number: 0001831750-2018-00945
• 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: 12/04/2018

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 Operator: No Information
• Device Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2017
• 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