MAUDE Adverse Event Report: INVACARE CORP. BED 36 INV 350LB FULL ELECTR; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number DEV5410IVC (RC350FE-BED)

Patient Problem Fall (1848)

Event Date 11/21/2022

Event Type  Injury  

Event Description

Spoke with patient's rn (b)(6) who advised patient fell and there were no injuries and no witnesses.Hospice has ordered a perimeter cover to prevent falls.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED 36 INV 350LB FULL ELECTR
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE CORP.
• MDR Report Key: 17567807
• MDR Text Key: 321544125
• Report Number: MW5144702
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DEV5410IVC (RC350FE-BED)
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female