MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TRURIZECLINICAL CHAIR; CHAIR, POSITIONING, ELECTRIC

Catalog Number 3333000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 11/26/2023

Event Type  Death  

Event Description

It was reported that a trauma patient was sitting in one of the electric recliners after working with staff to walk in the room.A few hours later the patient had experienced a cardiac arrest while in the chair.It was reported that they had to hold the recline button to get the patient supine.It was alleged that the bounce in the chair back made compressions less effective.It was reported that the patient passed away.

Manufacturer Narrative

No hazard or defect were alleged with the product.It is stated in the operations manual that trurize should not be used for cpr.Therefore, the death is not attributed to the trurize unit.The issue was resolved by the sales representative conducting additional training with the staff that the trurize cannot be used for cpr.

Event Description

It was reported that a trauma patient was sitting in one of the electric recliners after working with staff to walk in the room.A few hours later the patient had experienced a cardiac arrest while in the chair.It was reported that they had to hold the recline button to get the patient supine.It was alleged that the bounce in the chair back made compressions less effective.It was reported that the patient passed away.

• Brand Name: TRURIZECLINICAL CHAIR
• Type of Device: CHAIR, POSITIONING, ELECTRIC
• 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: 18654489
• MDR Text Key: 334699499
• Report Number: 0001831750-2024-00305
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 07613327322569
• UDI-Public: 07613327322569
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 3333000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 110 KG