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

Model Number	1040000
Medical Device Problem Codes	Circuit Failure (1089); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a report that a trilogy 202 ventilator was returned for routine preventive maintenance.There were no reports or allegations of patient harm or injury.The ventilator was returned to a third-party service center for evaluation.Review of the device log files identified a ¿ventilator service required¿ error indicating a loss of communication between the host controller and the oxygen blending module (obm).To address this issue, the oxygen blending module (obm) printed circuit assembly (pca) was replaced.Additionally, a separate ¿ventilator service required¿ error was identified indicating that the internal lithium-ion battery state of health was less than or equal to 50%, with full charge capacity (fcc) below 51% of the design capacity.This condition reflects expected battery life has declined due to use.The associated alarm is intended to notify the user that battery life has declined.While the battery is still functional and the device could continue to operate using ac power, the battery is no longer functioning to specification.The internal battery was replaced to address this condition.Following service, the device successfully passed all required functional and performance testing.

• Brand Name: TRILOGY 202
• 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: 24200354
• Report Number: 2518422-2026-003384
• Device Sequence Number: 13170705
• Product Code: CBK
• UDI-Device Identifier: 00606959022706
• UDI-Public: (01)00606959022706
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: 1040000
• Device Catalogue Number: 1040000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown