MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE.

Model Number	1125564B
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Viral Infection (2248); Unspecified Respiratory Problem (4464)
Date of Event	07/12/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging "the patient went to the hospital for covid, and then he returned at home with o2 (oxygen) prescription during the day and the ventilator during the night.The patient conditions decreased; a filter was added to the ventilator.The patient went into a coma due to a surplus of co2 (carbon dioxide).The patient died in the same month".The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
Additional Manufacturer Narrative
The manufacturer previously reported in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging "the patient went to the hospital for covid, and then he returned at home with o2 (oxygen) prescription during the day and the ventilator during the night.The patient conditions decreased; a filter was added to the ventilator.The patient went into a coma due to a surplus of co2 (carbon dioxide).The patient died in the same month".The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The manufacturer received information in reference to the device.The serial number has been provided and the device information has been updated from a philip's cpap device to a trilogy 200.This device is not part of the recall.The device has been returned to a third-party service center for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging "the patient went to the hospital for covid, and then he returned at home with o2 (oxygen) prescription during the day and the ventilator during the night.The patient conditions decreased; a filter was added to the ventilator.The patient went into a coma due to a surplus of co2 (carbon dioxide).The patient died in the same month".The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The manufacturer received information in reference to the device.The serial number has been provided and the device information has been updated from a philip's cpap device to a trilogy 200.This device is not part of the recall.The device has been returned to a third-party service center for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.This device is to be included in the recall.The h6 device problem code and the h7 have been updated to reflect this correction.

• Brand Name: TRILOGY 200
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE.
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17977075
• Report Number: 2518422-2023-27446
• Device Sequence Number: 16757732
• Product Code: CBK
• UDI-Device Identifier: 00606959027763
• UDI-Public: 00606959027763
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1125564B
• Device Catalogue Number: 1125564B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 04/24/2024; Not provided
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 04/25/2024; 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2018
• 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-1956-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown