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

Model Number	1032802
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for routine preventive maintenance.There was no allegation of device malfunction.There was no harm or injury reported.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 sensor board was replaced to address the issue.
Additional Manufacturer Narrative
Evaluation conclusion: the manufacturer previously reported the sensor board was replaced to address "service required" code.No components were replaced to address the "service required" code.The estimate was rejected and the device scrapped per the customer request.

• Brand Name: TRILOGY 200
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 6193036
• Report Number: 2518422-2016-04921
• Device Sequence Number: 18845225
• Product Code: CBK
• UDI-Device Identifier: 00606959022690
• UDI-Public: 00606959022690
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2016

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: 1032802
• Device Catalogue Number: 1032802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1