MAUDE Adverse Event Report: HILL-ROM CU TRIDENT STAT 5000 AP BARIATRIC MATRESS; BED, FLOTATION THERAPY, POWERED

Model Number CU TRIDIEN STAT 5000 AP BARI, MAT_A 36X80 TRIDIEN APL

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

Patient Problem Fall (1848)

Event Date 03/22/2021

Event Type  Injury  

Event Description

Pt.Has fallen from the mattress on a couple of different occasions.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CU TRIDENT STAT 5000 AP BARIATRIC MATRESS
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM
• MDR Report Key: 17534788
• MDR Text Key: 321057209
• Report Number: MW5141688
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 04/18/2021

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: CU TRIDIEN STAT 5000 AP BARI, MAT_A 36X80 TRIDIEN APL
• Device Catalogue Number: 3001020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1