MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1040000
Medical Device Problem Codes	Circuit Failure (1089); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a "service required" alarm condition occurred related to the oxygen blending module.The device was not in patient use.The device has not yet been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging a "service required" alarm condition occurred related to the oxygen blending module.The device was not in patient use.The device was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's oxygen blending module board needs replaced to address the issue.During the evaluation a malfunction of the acitve exhalation control module was observed.The active exhalation control module needs replaced to address the issue.

• Brand Name: TRILOGY 202
• 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; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12518290
• Report Number: 2518422-2021-04326
• Device Sequence Number: 4584529
• Product Code: CBK
• UDI-Device Identifier: 00606959022065
• UDI-Public: 00606959022065
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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: Health Professional
• Device Model Number: 1040000
• Device Catalogue Number: 1040000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown