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

Model Number	1032802
Medical Device Problem Code	Failure to Recalibrate (1517)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
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 step during testing.The device's active exhalation control module was replaced to address the issue.

• Brand Name: TRILOGY 200
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11294046
• Report Number: 2518422-2021-00287
• Device Sequence Number: 3737566
• Product Code: CBK
• UDI-Device Identifier: 00606959022690
• UDI-Public: 00606959022690
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

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: 1032802
• Device Catalogue Number: 1032802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1