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

Model Number	1054096
Medical Device Problem Codes	Circuit Failure (1089); Degraded (1153)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2019
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, a "service required" code was found in the ventilator's downloaded error log.The device's system board was replaced to address the issue.
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 a ventilator was returned to the manufacturer for routine preventive maintenance.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, a "service required" code was found in the ventilator's downloaded error log.The device's system board was replaced to address the issue.The coding has been updated to reflect the fsn for sound abatement foam degradation.

• Brand Name: TRILOGY 100
• 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 lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; head of quality, src; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 8539584
• Report Number: 2518422-2019-00866
• Device Sequence Number: 400548
• Product Code: CBK
• UDI-Device Identifier: 00606959021662
• UDI-Public: 00606959021662
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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: 1054096
• Device Catalogue Number: 1054096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2013
• 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