MAUDE Adverse Event Report: STRYKER MEDICAL TRURIZE CHAIR POWERED CLINICAL CHAIR; CHAIR, POSITIONING, ELECTRIC

Model Number 3333000000

Device Problems Device Alarm System (1012); Material Twisted/Bent (2981)

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

Event Date 01/06/2020

Event Type  Injury  

Event Description

On the date of the event, icu pt was assisted up in the trurize chair by an rn and pct.The pt's nurse had tested the chair while she was in the pt's room by sitting in the chair and getting up.The chair alarm sounded for the test.The chair was plugged into the call system as per proper procedure.After the nurse tested the chair, she assisted the pt with breakfast and then left the room.Approx 90 mins after the pt was assisted up, a loud thud was heard in the hallway outside of the pt's room by the clinical mgr of icu.The pt had exited the chair, and the call system alarm did not sound in the hallway.The pt was taken to radiology for a ct of the head and neck.The pt was found to have a large hematoma and small subarachnoid hemorrhage.Pt was nonverbal when the incident occurred but became verbal within a few mins.Two subsequent ct scans of the head were completed the 2 days following the incident, that showed decreasing size of the hematoma and stable sah.Upon inspection of the trurize chair after the event, 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.The chair was taken immediately out of service and the clinical engineering dept fixed the faulty prong.The other mfr was notified of the event along with the other nursing dept that had trurize chairs to let know of the issue with the prong.Fda safety report id# (b)(4).

• Brand Name: TRURIZE CHAIR POWERED CLINICAL CHAIR
• Type of Device: CHAIR, POSITIONING, ELECTRIC
• Manufacturer (Section D): STRYKER MEDICAL
• MDR Report Key: 9877736
• MDR Text Key: 185084071
• Report Number: MW5093914
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3333000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 60