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

Model Number	1040000
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	02/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred.The device was not in patient use.The device was returned to the manufacturer's service center for evaluation, but the device evaluation is not yet finished.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 ventilator inoperative condition occurred and the device was not in patient use.The device was evaluated by a field service engineer and the customer's complaint was not confirmed.A "service required" code was found in the ventilator's downloaded event log and the device failed steps during testing.The device's oxygen blending module board needs replaced to address the issues.

• Brand Name: TRILOGY 202
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11453689
• Report Number: 2518422-2021-00680
• Device Sequence Number: 17018460
• 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): 03/29/2021

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: 03/08/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1