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

Model Number	1032804
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
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 manufacturer's service center, the lcd screen was observed black and unable to be viewed.The device's lcd display was replaced to address the issue.
Additional Manufacturer Narrative
The manufacturer previously reported, 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 manufacturer's service center, the lcd screen was observed black and unable to be viewed.The device's lcd display was replaced to address the issue.The lcd display was evaluated by the manufacturer's product investigation laboratory (pil) and found the lcd display functioned as designed and operated without issue or error codes.

• Brand Name: TRILOGY 200
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC.; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15743875
• Report Number: 2518422-2022-91100
• Device Sequence Number: 15222465
• Product Code: CBK
• UDI-Device Identifier: 00606959025370
• UDI-Public: 00606959025370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: 1032804
• Device Catalogue Number: 1032804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2016
• 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