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

Model Number	1032800
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator's lcd screen was blank.The device was not in patient use.The device was evaluated at the manufacturer's service center and the customer's complaint was confirmed.The device's lcd screen was replaced to address the issue.

• Brand Name: TRILOGY 200
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• MDR Report Key: 7999472
• Report Number: 2518422-2018-02467
• Device Sequence Number: 203493
• Product Code: CBK
• UDI-Device Identifier: 00606959026360
• UDI-Public: 00606959026360
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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: 10/01/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1