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

Model Number	BR1040000
Medical Device Problem Codes	Circuit Failure (1089); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator failed to initialize ventilation.The device was not in patient use.The device has not yet been returned to the third party service center.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the third party investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported a ventilator failed to initialize ventilation.The device was returned to a third party service center, and the customer's complaint was confirmed.A ventilator inoperative alarm condition was observed.The device's system board needs to be replaced to address the issue.

• Brand Name: TRILOGY 202
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• MDR Report Key: 11454030
• Report Number: 2518422-2021-00681
• Device Sequence Number: 3497264
• Product Code: CBK
• UDI-Device Identifier: 00606959022096
• UDI-Public: 00606959022096
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: BR1040000
• Device Catalogue Number: BR1040000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1