FDA Adverse Event Malfunction Summary report: N

TRILOGY EVO

MDR report key: 22464553 · Received July 9, 2025

Report

Report Number
2518422-2025-107224
Event Type
Malfunction
Date Received
July 9, 2025
Date of Event
June 30, 2025
Report Date
July 9, 2025
Manufacturer
RESPIRONICS, INC.
Product Code
CBK
PMA / PMN Number
K181166
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
KS
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION HAD OCCURRED ON THE TRILOGY EVO DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE MANUFACTURER¿S SERVICE TECHNICIAN CONFIRMED THE CUSTOMER¿S ISSUE AND OBSERVED ERROR CODES THERAPY HELD IN BOOT MONITOR, MOTOR SHUTDOWN, AND ACTIVE EXHALATION CONTROL MODULE FAILURE IN THE DEVICE¿S EVENT LOG. THE MANUFACTURER¿S SERVICE TECHNICIAN REPLACED THE DEVICE'S SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD AND BLOWER ASSEMBLY TO ADDRESS THE THERAPY HELD IN BOOT MONITOR AND MOTOR SHUTDOWN ISSUE. THE DEVICE'S PROPORTIONAL VALVE AND THREE-WAY SOLENOID VALVE WERE REPLACED TO ADDRESS THE ACTIVE EXHALATION CONTROL MODULE FAILURE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WERE ADDITIONAL ERROR CODES, MOTOR CONTROLLER FOC SHUTDOWN AND MOTOR FLUX MAGNITUDE RUNTIME, THAT WERE OBSERVED BY THE MANUFACTURER¿S SERVICE TECHNICIAN. THE MANUFACTURER¿S SERVICE TECHNICIAN REPLACED THE DEVICE'S SYSTEM PCA BOARD AND BLOWER ASSEMBLY TO ADDRESS THE MOTOR CONTROLLER FOC SHUTDOWN AND MOTOR FLUX MAGNITUDE RUNTIME ISSUES. AFTER ALL OF THE PARTS WERE REPLACED, THE MANUFACTURER¿S SERVICE TECHNICIAN UPGRADED THE SOFTWARE VERSION AND PERFORMED THE FINAL TEST ON THE DEVICE. THE DEVICE PASSED THE TEST.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1729649 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. KR2110X15B

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown