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

Model Number STAT 2 LAL/AP

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

Patient Problem Fall (1848)

Event Date 03/06/2017

Event Type  malfunction  

Event Description

The resident was found on the floor.No other info was given.No injuries to patient.Patient was not seen by doctor or sent to hospital.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: 17531793
• MDR Text Key: 321374365
• Report Number: MW5138705
• 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: 03/07/2017

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: STAT 2 LAL/AP
• Device Lot Number: SASHORTMATT, SA MAX
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 50 YR