MAUDE Adverse Event Report: INVACARE CORP. INVACARE HOSPITAL BED; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number 5301IVC

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 01/03/2022

Event Type  Injury  

Event Description

We had an invacare hospital bed model 5301ivc installed around (b)(6) 2021 for my father who had a stroke.On (b)(6) 2022 when getting out of bed he fell while holding the footboard and as his arm slid down the outside of the footboard, he was seriously injured by a mechanism that protrudes out from under the bed.This bed has a portion of the driveshaft mechanism that raises and lowers the bed protruding out past the edge of the footboard.The portion that protrudes out has a very sharp groove/opening and severely cut my father's arm as he slid down the outside of the footboard.The manufacturer informed us that they have no cover designed for this protrusion.My father was hospitalized for over two weeks recovering from his injury.Fda safety report id # (b)(4).

• Brand Name: INVACARE HOSPITAL BED
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVACARE CORP.
• MDR Report Key: 13446201
• MDR Text Key: 285148804
• Report Number: MW5107191
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 5301IVC
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White