[185084071]
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).
Patient Sequence No: 1, Text Type: D, B5