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

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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/28/2017

Event Type  Injury  

Event Description

Patient slid 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 MATT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MOXI ENTERPRISE, LLC
• MDR Report Key: 17537265
• MDR Text Key: 321150872
• Report Number: MW5144145
• 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: 02/04/2017

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 SA MAX APL CONTROL UNIT, MOXI LAL 36X80 MATTRESS
• Patient Sequence Number: 1