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

Model Number 5410LOW

Device Problem Mechanical Jam (2983)

Patient Problem Fall (1848)

Event Date 08/06/2019

Event Type  Injury  

Event Description

(b)(6) registered nurse called in a service to report that frame would not go up and down.While reporting this she mentioned that she was told the patient fell out of the bed.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: 17537407
• MDR Text Key: 321158961
• Report Number: MW5144285
• 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: 08/17/2019

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