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

Model Number MOXI LAL 36X80 MATTRESS, MOXI APL CONTROL UNIT

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

Patient Problem Fall (1848)

Event Date 02/25/2017

Event Type  malfunction  

Event Description

Patient was on the facility owned stryker bed frame with maxi lal mattress.Patient pulled herself using the side rail to the edge of the mattress, causing herself to fall between the side rails to the floor.Charge nurse placed an order for a new bed and fall pads at that time.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MOXI SA MAX
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MOXI ENTERPRISES, LLC
• MDR Report Key: 17536811
• MDR Text Key: 321347813
• Report Number: MW5143695
• 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: 03/06/2017

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: MOXI LAL 36X80 MATTRESS, MOXI APL CONTROL UNIT
• Device Lot Number: SASHORTMATT, SA MAX
• Patient Sequence Number: 1
• Patient Age: 78 YR