MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 202 VENTILATOR, U.S.A.; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1040007
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy 202 ventilator, u.S.A.Was returned to the manufacturer for routine preventative maintenance.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the trilogy 202 ventilator, u.S.A.Device at the manufacturer's service center, a "service required" err_prox_press_railed error code was discovered in the ventilator's downloaded event log.The technician documented per service guide, this error could indicate faulty tubing, obm manifold, sensor board cable, and/or sensor board.The tubing will be checked for leaks and replace them if necessary.There is no documentation of any component needing to be replaced.The customer cancelled repair.The device to be returned unrepaired.Additionally, the device's pollen filter, sd card, and case were replaced per periodic maintenance.The power cord, c7-end, r.A.Female-end, us, power cord clamp, and plastic threaded cap were replaced due to having been missing at inspection.The housing and front enclosure kit were replaced having been damaged at inspection.

• Brand Name: TRILOGY 202 VENTILATOR, U.S.A.
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24027672
• Report Number: 2518422-2026-001546
• Device Sequence Number: 8970337
• Product Code: CBK
• UDI-Device Identifier: 00606959005150
• UDI-Public: (01)00606959005150
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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?: Yes
• Device Model Number: 1040007
• Device Catalogue Number: 1040007
• Device Lot Number: 160610
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown