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

Model Number TRIDIEN STAT 5000 AP CONTROL UNIT, TRIDIEN APL 36X80 MATTRESS, SR371 , 3001020

Device Problem Deflation Problem (1149)

Patient Problems Fall (1848); Pain (1994)

Event Date 08/11/2017

Event Type  Injury  

Event Description

(b)(6) stated when the nurse went in she noticed that mattress was deflated.Patient was on the floor no injuries.Patient complained of soreness to hip and pain.X rays were done.Lab came in confirmation of all test completed and only pain was reported as findings from test.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRIDIEN APL MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): TRIDIEN
• MDR Report Key: 17530010
• MDR Text Key: 321134824
• Report Number: MW5136930
• 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: 08/28/2017

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: TRIDIEN STAT 5000 AP CONTROL UNIT, TRIDIEN APL 36X80 MATTRESS, SR371 , 3001020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 88 YR