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

Catalog Number	3333000000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/26/2023
Type of Reportable Event	Death
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0001831750-2024-00305
• Device Sequence Number: 7187339
• Product Code: INO
• UDI-Device Identifier: 07613327322569
• UDI-Public: 07613327322569
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2024
• Supplement Date Received by Manufacturer: 01/21/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 110 KG