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

Model Number	1032800
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from a third party service center alleging a ventilator's active exhalation control valve remained open.There was no report of patient harm or injury.The device has not yet been evaluated by the manufacturer.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 has completed the evaluation of a ventilation with the allegation the device's active exhalation control valve remained open.During the evaluation of the device at the manufacturer's service center, the customer's complaint was not confirmed.
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of previously closed complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.The manufacturer previously reported receiving information from a third party service center alleging a ventilator's active exhalation control valve remained open.There was no report of patient harm or injury.The device was retunred to the manufacurer for evaluation and the customer's complaint could not be confirmed.During the evaluation, dust and debris contamination was observed in the inlet air path, inlet air path foam, blower and flow sensor assembly.The inlet air path, air path foam blower and flow sensor assembly were 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
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 5474283
• Report Number: 2518422-2016-00995
• Device Sequence Number: 341000
• Product Code: CBK
• UDI-Device Identifier: 00606959022829
• UDI-Public: 606959022829
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2022

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: 1032800
• Device Catalogue Number: 1032800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2016
• Supplement Date Received by Manufacturer: Not provided; 05/03/2016
• Initial Report FDA Received Date: 03/02/2016
• Supplement Report FDA Received Date: 05/04/2016; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FDA RES 88071
• Patient Sequence Number: 1
• Patient Sex: Unknown