MAUDE Adverse Event Report: GRAHAM-FIELD EVEREST & JENNINGS; COMPANION CHAIR

Model Number IOSO83WC0319

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 06/11/2018

Event Type  Death  

Event Description

Am, an assisted living facility resident, fell forward out of the wheelchair, landing on her face.Was sent to hosp where she was found to have sustained a fractured nose, and lacerations to the nose and upper lip, which required sutures.She was returned to the alf and demonstrated decline over the next days, dying on (b)(6) 2018.

• Brand Name: EVEREST & JENNINGS
• Type of Device: COMPANION CHAIR
• Manufacturer (Section D): GRAHAM-FIELD; one graham field way; atlanta GA 30340
• MDR Report Key: 7788233
• MDR Text Key: 117443172
• Report Number: 7788233
• Device Sequence Number: 1
• Product Code: IML
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IOSO83WC0319
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2018
• Distributor Facility Aware Date: 06/11/2018
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 08/14/2018
• 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): Death
• Patient Age: 91 YR
• Patient Weight: 57