MAUDE Adverse Event Report: TRIDIEN MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number STAT 5000 MATTRESS AND CONTROL UNIT

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2018

Event Type  malfunction  

Event Description

Fst received a service ride (b)(4) for a deflated mattress.When he was about 10 minutes out he called to have staff go ahead and remove patient off mattress.They said that the mattress was fine but that the patient fell of mattress because it was not completely secured to bed frame.He arrived and secured the mattress to the bed frame.Appreciate that the bed frame is an old carrol.There are not many places to secure straps to this type of frame.I called and spoke to irma rodriguez who called in the order.She said that the patient did not fall on the floor.But that the patient caught himself by using the side rail.She said patient is fine.N/a.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): TRIDIEN
• MDR Report Key: 17528040
• MDR Text Key: 321406377
• Report Number: MW5134971
• 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: 09/14/2018

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
• Device Model Number: STAT 5000 MATTRESS AND CONTROL UNIT
• Device Catalogue Number: 5000C, 3001020
• Patient Sequence Number: 1