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

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

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

Patient Problems Fall (1848); Headache (1880)

Event Date 08/16/2017

Event Type  Injury  

Event Description

Was in bed asleep on 11-7 shift, heard a thud and patient was lying on her back with her head on the floor.Patient said she hit her head and was complaining of severe headaches.911 was called and then the patient was taken to the hospital.Additional information: service to have equipment switched out and quarantined.(b)(6) (don) stated she would like a report of the outcome of the examination of the mattress emailed to her to place in the report.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: 17530162
• MDR Text Key: 321092209
• Report Number: MW5137082
• 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

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: TRIDIEN APL 36X80 MATTRESS; TRIDIEN STAT 5000AP CONTROL UNIT, 3001020, 5000C
• Patient Sequence Number: 1
• Patient Age: 85 YR