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

Model Number	1040005
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging visualization of particles in the air path.There was no report of serious patient harm or injury.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 receiving information alleging visualization of particles in the air path.There was no harm or injury reported.The device was evaluated by the manufacturer's product investigation laboratory (pil) and the customer's complaint could not be confirmed.Disassembly and visual inspection of the air path assembly, air path foam, and the unit flow path resulted in no non conforming material (ncm), no contamination, or black foam related particles in the trilogy air path assembly, the air path foam or flow path portions of the trilogy ventilator.The trilogy air path assembly and air path foam were found to be intact with no signs of foam degradation.

• 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: kimberly shelly ; 6501 living place; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14915049
• Report Number: 2518422-2022-58574
• Device Sequence Number: 5814127
• Product Code: CBK
• UDI-Device Identifier: 00606959026223
• UDI-Public: 00606959026223
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: Lay User/Patient
• Device Model Number: 1040005
• Device Catalogue Number: 1040005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2011
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FDA RES 88071
• Patient Sequence Number: 1
• Patient Sex: Unknown