MAUDE Adverse Event Report: MOXI MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 1-2. ST AT 5000CB - SA48MA TT

Device Problem Unintended System Motion (1430)

Patient Problem Fall (1848)

Event Date 05/17/2021

Event Type  Injury  

Event Description

On (b)(6) and (b)(6) slid from mattress due to air moving.(b)(6) he has fallen twice.Service order was done by (b)(6) on (b)(6) 2021.I asked her about this issue and she replied hello, i checked the pr request.(b)(6) had assisted (b)(4) regarding this order.I do not see that there was a report created." so i did the qvr (b)(4) service no covid-19.(b)(6) foam mattress - please bring to switch out the air mattress.Per (b)(6) (b)(6) 2021 2:57 pm): if they are looking to return the lal and switch to foam.Please create a service to have it switched out.The bed they ordered includes a foam matt in the rental rate, so nothing to add.Action required: the manufacturer was notified june 25, 2021.(b)(4) service (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MOXI
• MDR Report Key: 17533215
• MDR Text Key: 321162586
• Report Number: MW5140119
• 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: 06/25/2021

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. ST AT 5000CB - SA48MA TT
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 71 YR