MAUDE Adverse Event Report: INVACARE INVACARE 350LB BED; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number 5410IVC

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Fall (1848)

Event Date 10/16/2019

Event Type  Injury  

Event Description

Patient has side rails on the bed that have a gap in the middle of them.The patient was able to get out of bed through the gap and fell off the bed.There were no injuries and no witnesses.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE 350LB BED
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17534447
• MDR Text Key: 321158255
• Report Number: MW5141348
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5410IVC
• Patient Sequence Number: 1