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

Model Number	1058180
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/28/2016
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 internal battery was replaced to address the issue.

• Brand Name: TRILOGY 100
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 5808832
• Report Number: 2518422-2016-03090
• Device Sequence Number: 13599896
• Product Code: CBK
• UDI-Device Identifier: 00606959022768
• UDI-Public: 00606959022768
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2016

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: 1058180
• Device Catalogue Number: 1058180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2016
• Initial Report FDA Received Date: 07/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1