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

Model Number	1040007
Medical Device Problem Codes	Failure to Charge (1085); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this report, the device has reached the end of its service agreement and has exceeded its established service life.As such, the device is no longer eligible for repair, and replacement parts are no longer available.All applicable warranties have expired.The manufacturer is submitting this final report to document closure of the case.No additional information is reasonably expected, as the device is no longer serviceable and further evaluation cannot be performed.No further investigation is required, as the risk of this failure mode is well-documented within the risk management process.Device labeling indicates that batteries used in trilogy devices are anticipated to wear out after a long period of use, dependent on factors such as storage temperature and amount of use (full charge-discharge cycles).Ac power, detachable battery, and external dc power port can continue to be used to provide therapy in the event of an internal battery failure when an alternative mode of ventilation is not available.The device successfully monitored the state of health of the internal battery and alerted the user via an alarm, prior to the device being unplugged from ac, as designed.All risk control methods are determined to be within risk acceptance criteria, and this complaint does not constitute an elevated risk.
Event or Problem Description
The manufacturer received information that a trilogy 202 ventilator internal battery was depleted and would not charge when plugged in.The device was not in use on a patient at the time of the occurrence.During the evaluation of the device the customers complaint was confirmed.The device was serviced by a remote service engineer, and it was determined that the battery has reached its end of support with no parts or repair available.The customer was provided with a discontinue letter.The technician determined the system does not meet the specification for the performed service and is not returned to use.If any additional information is received, a follow-up report will be filed.

• 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: 24494134
• Report Number: 2518422-2026-007459
• Device Sequence Number: 5017040
• Product Code: CBK
• UDI-Device Identifier: 00606959005150
• UDI-Public: (01)00606959005150
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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
• Operator of Device: Other
• Device Model Number: 1040007
• Device Catalogue Number: 1040007
• Device Lot Number: 150211
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2015
• 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