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

Model Number	1032800
Medical Device Problem Codes	Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for service.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, the device failed a test step during testing.The device's active exhalation control module was replaced to address the issue.
Additional Manufacturer Narrative
The manufacturer previously reported a ventilator's active exhalation control module was replaced due to a failed test step.During further evaluation the device's sensor board was replaced to address a "service required" alarm condition.The device's sensor board was returned to the manufacturer's quality assurance laboratory for further investigation.The root cause of the sensor board failure was due to the pressure sensors mt3 and mt2 being out of tolerance.

• Brand Name: TRILOGY 200
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• MDR Report Key: 7285213
• Report Number: 2518422-2018-00380
• Device Sequence Number: 11176590
• Product Code: CBK
• UDI-Device Identifier: 00606959026360
• UDI-Public: 00606959026360
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 1032800
• Device Catalogue Number: 1032800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1