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

Model Number	CA1032800B
Medical Device Problem Code	Failure to Recalibrate (1517)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator failed a test step during testing.The device was not in patient use.The ventilator was returned to the manufacturer for evaluation.The ventilator's internal tubing was found to be pinched, which would cause the device to fail testing.The device's tubing kit was replaced to address the issue.
Additional Manufacturer Narrative
The manufacturer previously reported a ventilator failed a test step during testing.The device's tubing kit was found to be pinched and was replaced to address the issue.During additional evaluation of the device at the manufacturer's service center, the device failed test steps again during testing.The device's active exhalation control module needs to be replaced to address the issues.

• Brand Name: TRILOGY 200
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12134779
• Report Number: 2518422-2021-02102
• Device Sequence Number: 1621907
• Product Code: CBK
• UDI-Device Identifier: 00606959026452
• UDI-Public: 00606959026452
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093416
• 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): 08/05/2022

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: CA1032800B
• Device Catalogue Number: CA1032800B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2019
• 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