FDA Adverse Event Malfunction Summary report: N

TRILOGY 100

MDR report key: 23041749 · Received September 12, 2025

Report

Report Number
2518422-2025-110126
Event Type
Malfunction
Date Received
September 12, 2025
Date of Event
August 29, 2025
Report Date
September 12, 2025
Manufacturer
RESPIRONICS, INC.
Product Code
CBK
UDI-DI
00606959026353
PMA / PMN Number
K083526
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
LA, US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

THE MANUFACTURER RECEIVED INFORMATION FROM A PHILIPS SERVICE TECHNICIAN THAT THE LOW FLOW OXYGEN (O2) TEST STEP HAD FAILED ON THE TRILOGY 100 DEVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE PHILIPS SERVICE TECHNICIAN EVALUATED AND DETERMINED THE INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH TUBING HAD CAUSED THE LOW FLOW O2 TEST STEP TO FAIL ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN REPLACED THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH TUBING TO ADDRESS THIS ISSUE ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN RE-PERFORMED ALL TESTING ON THE DEVICE, BUT THE LOW O2 FLOW TEST STEP HAD FAILED AGAIN ON THE DEVICE. THE PHILPS SERVICE TECHNICIAN RE-EVALUATED THE DEVICE AND FOUND THE GREY FOAM WAS NOT PROPERLY INSTALLED CAUSING THE LOW O2 FLOW TEST STEP TO FAIL ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN PROPERLY ALIGNED THE DEVICE'S GREY REMOVABLE FOAM ON THE DEVICE TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS EXTERIOR DAMAGE WHICH WAS NOT CONFIRMED BY THE PHILIPS SERVICE TECHNICIAN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2027159 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260B 00606959026353

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown