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

Model Number 3333

Device Problem No Audible Alarm (1019)

Patient Problems Fall (1848); Hematoma (1884); Hemorrhage, Subarachnoid (1893)

Event Date 12/24/2019

Event Type  Injury  

Manufacturer Narrative

Upon inspection of the trurize chair after the event by the user facility, the cord that attached it to the staff call system was found to have a bent prong.The bent prong did not allow the chair exit alarm to be connected to the call system.

Event Description

It was reported in mw5093914 that a patient had exited the chair, and the call system alarm did not sound in the hallway.The patient was taken to radiology for a ct scan of the head and neck.The patient was found to have a large hematoma and small subarachnoid hemorrhage.The patient was nonverbal when the incident occurred but became verbal within a few minutes.Two subsequent ct scans of the head were completed the 2 days following the incident, that showed decreasing size of the hematoma and stable subarachnoid hemorrhage.

• Brand Name: TRURIZE
• 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: 10004882
• MDR Text Key: 189772594
• Report Number: 0001831750-2020-00546
• 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: Other
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3333
• Device Catalogue Number: 3333000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2017
• 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
• Patient Outcome(s): Required Intervention