MAUDE Adverse Event Report: MOXI ENTERPRISES, LLC LOW AIR LOSS - 36 X 80 - VAL; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 1-2. SASTDMATT,SAMEDASTMAXUMP

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

Patient Problem Fall (1848)

Event Date 11/10/2020

Event Type  Injury  

Event Description

Found on the floor, was trying to roll over to get out of bed and fell.Patient isn't supposed to be getting up by herself caller stated.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LOW AIR LOSS - 36 X 80 - VAL
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MOXI ENTERPRISES, LLC
• MDR Report Key: 17524689
• MDR Text Key: 321133177
• Report Number: MW5131634
• 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: 11/12/2020

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: 1-2. SASTDMATT,SAMEDASTMAXUMP
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1