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

Model Number 5410LOW

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 06/10/2019

Event Type  Injury  

Event Description

Caregiver called (b)(6) 2019 in the am and requested rails because the patient fell out of bed a few times this week.Patient does not have any complaints or injuries.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE HI-LO BED
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17524151
• MDR Text Key: 321132430
• Report Number: MW5131098
• 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: 07/09/2019

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: 5410LOW
• Patient Sequence Number: 1
• Patient Age: 58 YR