MAUDE Adverse Event Report: INVACARE CORP. RC 350 LB FULL ELECT BED W/H RL; BED, AC-POWERED ADJUSTABLE HOSPITAL

Lot Number RC 350LB FULL ELEC BD W/ H RL,

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

Patient Problem Fall (1848)

Event Date 02/17/2021

Event Type  Injury  

Event Description

Wife reported patient fell out of bed.Wife called non-emergency triage (b)(6) after hrs.This was called to have help with picking patient up off the floor.Negative covid 19.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RC 350 LB FULL ELECT BED W/H RL
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE CORP.
• MDR Report Key: 17528804
• MDR Text Key: 321037623
• Report Number: MW5135733
• Device Sequence Number: 1
• Product Code: FNL
• 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: 02/18/2021

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 Lot Number: RC 350LB FULL ELEC BD W/ H RL,
• Patient Sequence Number: 1
• Patient Age: 55 YR