MAUDE Adverse Event Report: INVACARE HALF RAILS

Model Number 6630

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

Patient Problem Fall (1848)

Event Date 11/26/2018

Event Type  Death  

Event Description

On call rn received call stating pt had passed and daughter was hysterical.When ocrn arrived at the home, pt was deceased and kneeling on the left side of the bed with her head entrapped between the bed frame and half side rail.

• Brand Name: HALF RAILS
• Type of Device: HALF RAILS
• Manufacturer (Section D): INVACARE; 1 invacare way; elyria OH 44035
• MDR Report Key: 8128953
• MDR Text Key: 129308008
• Report Number: 8128953
• Device Sequence Number: 1
• Product Code: FNL
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6630
• Device Lot Number: HL150105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2018
• Distributor Facility Aware Date: 11/26/2018
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 11/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2018
• 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: 84 YR
• Patient Weight: 88