MAUDE Adverse Event Report: MOXI ENTERPRISES, LLC MOXI SA MAX CONTROL UNIT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number MOXI SA MAX CONTROL UNIT, MOXI LAL 36X80 MATTRESS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2017

Event Type  malfunction  

Event Description

Patient rolled off of mattress and held onto the rail of the bed frame.Immediately staff came and helped patient.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MOXI SA MAX CONTROL UNIT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MOXI ENTERPRISES, LLC
• MDR Report Key: 17525135
• MDR Text Key: 321440764
• Report Number: MW5132077
• 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: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: MOXI SA MAX CONTROL UNIT, MOXI LAL 36X80 MATTRESS
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 81 YR