MAUDE Adverse Event Report: Respironics, Inc. Trilogy100 Ventilator, U.S.A.; Ventilator, Continuous, Facility Use

Model Number	1054260
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy 100 ventilator was returned to a third-party service center in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no report of patient harm or injury.During the evaluation at the third-party service center, the device was visually inspected, and foam particles were observed.The device was remediated, and the foam insulation needs to be replaced to resolve the issue.The device will be scrapped; therefore, no additional repair information was provided.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a supplemental report will be completed.
Additional Manufacturer Narrative
The affected products with field complaints alleging pe-pur foam degradation have undergone the establishment of complaint codes specifically identifying foam degradation, for the trilogy series.A field correction action(2021-05-a) was initiated, and medical device recall letters were issued.A field action was initiated to replace pe-pur foam in affected products; degradation was added to the respective dfmeas and the risk management file¿ (b)(4) (trilogy risk matrix) was updated to include hazards associated with foam degradation based on complaints analyzed through various health hazard evaluations (hhes).Risk tags ¿ allergy01, toxic01 reflect the safety risk assessment of design containing the affected pe-pur foam.These complaints were monitored and trended in accordance with the complaint trending procedures.If the complaints were determined to meet the criteria for escalation, they were escalated for risk assessment through the post market clinical escalation process.As of the date of submission for this report, there is no indication that complaints for the failure in question have led to unacceptable levels of severity or probabilities of harm, and therefore no further action will be pursued.The device exceeds expected life so there is no dhr required at this time.

• Brand Name: Trilogy100 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 ; +1(724)733-0200
• MDR Report Key: 50899198
• Report Number: 2518422-2026-046479
• Device Sequence Number: 21523025
• Product Code: CBK
• UDI-Device Identifier: 00606959015364
• UDI-Public: (01)00606959015364
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 1054260
• Device Catalogue Number: 1054260
• Device Lot Number: 130626
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2013
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0882-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown