MAUDE Adverse Event Report: UNKNOWN UNKNOWN; CHAIR, EXAMINATION AND TREATMENT

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 10/31/2016

Event Type  malfunction  

Event Description

The pt attempted to sit in the recliner but sat on the leg rest, causing pt to fall.No external injuries were noted.The pt denies pain.Their doctor was made aware, we will continue to monitor.Cannot get any manufacture info off of the chair.Patient simply sat on the foot rest instead of into the chair seat and fell/slid off.No injuries occurred.All physicians were notified at time of incident.A post fall huddle was performed at the patient's bedside following the incident.

• Brand Name: UNKNOWN
• Type of Device: CHAIR, EXAMINATION AND TREATMENT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6431596
• MDR Text Key: 70789982
• Report Number: 6431596
• Device Sequence Number: 1
• Product Code: FRK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR