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

Model Number	1125564B
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Viral Infection (2248); Unspecified Respiratory Problem (4464)
Date of Event	04/24/2024
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 allegation 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 in a coma due a surplus of co2 (carbon dioxide).The patient died in the same month.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be requested at this time.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
H3 other text : the device has yet to be returned to the manufacturer.

• Brand Name: TRILOGY 200, AERIS
• 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: 19237358
• Report Number: 2518422-2024-24818
• Device Sequence Number: 8107076
• Product Code: CBK
• UDI-Device Identifier: 00606959027763
• UDI-Public: 00606959027763
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1125564B
• Device Catalogue Number: 1125564B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2016
• 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