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

Model Number TRIDIEN STAT 5000 AP BARI CONTROL UNIT, TRIDIEN APL 36X80 MATTRESS

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 01/20/2018

Event Type  Injury  

Event Description

Head of bed was up and the patient slid out near foot area of bed and was found on ground.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: 17535300
• MDR Text Key: 321148067
• Report Number: MW5142199
• 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: 01/23/2018

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: TRIDIEN STAT 5000 AP BARI CONTROL UNIT, TRIDIEN APL 36X80 MATTRESS
• Device Catalogue Number: 5000C, 3001020
• Patient Sequence Number: 1
• Patient Age: 87 YR