MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1054260
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2015
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A ventilator was returned to the manufacturer for routine preventative maintenance.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at the third party service center, the device's inlet air path assembly and air path foam was replaced due to contamination.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported the investigation was ongoing and a follow up report would be submitted when the investigation was complete.No follow up report is required.Additionally, it was previously reported in section b5 that the device was evaluated at a third party service center.The device was evaluated by the manufacturer.

• Brand Name: TRILOGY 100
• 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 ; head of quality, src; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13633850
• Report Number: 2518422-2022-06187
• Device Sequence Number: 13994062
• Product Code: CBK
• UDI-Device Identifier: 00606959026322
• UDI-Public: 00606959026322
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2015
• Supplement Date Received by Manufacturer: 12/21/2015
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2010
• 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