MAUDE Adverse Event Report: GENDRON; MOXI 1)MAXIREST, SELECT AIR MAX; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 11/04/2018

Event Type  Injury  

Event Description

Patient was trying to reach for bed control, and "slid" out of the bed.Patient was found on the floor with no apparent injuries.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 1)MAXIREST, SELECT AIR MAX
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GENDRON; MOXI
• MDR Report Key: 17534044
• MDR Text Key: 321159459
• Report Number: MW5140947
• 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: 11/06/2018

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
• Patient Sequence Number: 1
• Treatment: FNM MATTRESS , AIR FLOTATION, ALTERNATING PRESSURE.