MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200 VENTILATOR, U.S.A. - BT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1040005B
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A ventilator was returned to the manufacturer for service.There was no serious patient harm or injury that occurred or was reported.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, an error code related to the internal battery was observed.Err_perm_fail_int_li_ion means there was an internal li-ion battery permanent failure.The internal battery pack needs replaced to address the issue.Additionally, during the evaluation of the device at the manufacturer's service center, an urgent reminder error code was observed.Err_urgent_reminder is a notification to the user that one or more ¿ventilator service required¿ errors are active in the system.This is informational.Also, during the evaluation of the device at the manufacturer's service center, the front case enclosure, rear case enclosure and base enclosure assembly were found to have damage and replaced.The device was found to have missing/displaced rubber feet, issue address with replacement of base enclosure assembly.The cord retainer was found to be missing/broken, the cable clamp was replaced.The porting block port was found to be pinched/damaged, the universal porting block replaced.

• Brand Name: TRILOGY 200 VENTILATOR, U.S.A. - BT
• 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: 23349387
• Report Number: 2518422-2025-111199
• Device Sequence Number: 20776070
• Product Code: CBK
• UDI-Device Identifier: 00606959026445
• UDI-Public: (01)00606959026445
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: 1040005B
• Device Catalogue Number: 1040005B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2014
• 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