MAUDE Adverse Event Report: INVACARE INVACARE 350LB BED; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 5410LOW

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 09/24/2019

Event Type  Injury  

Event Description

Facility stated that patient slipped off of the bed twice as he was trying to get up.There was someone in the room trying to assist him but he was agitated and combative (he was hitting her) so she let him slip down to the floor and then he got up again.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: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17537379
• MDR Text Key: 321141376
• Report Number: MW5144257
• Device Sequence Number: 1
• Product Code: FNM
• 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: 10/15/2019

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