MAUDE Adverse Event Report: MOXI ENTERPRISE, LLC MOXI SELECT AIR MAX; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Lot Number SA MAX, SANOFTMATT

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

Patient Problem Fall (1848)

Event Date 01/22/2017

Event Type  Injury  

Event Description

Patient fell out of bed.Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MOXI SELECT AIR MAX
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MOXI ENTERPRISE, LLC
• MDR Report Key: 17532856
• MDR Text Key: 321134611
• Report Number: MW5139763
• 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: 02/06/2017

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 Lot Number: SA MAX, SANOFTMATT
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1