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

Model Number	1032804
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2017
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient became disconnected from a ventilator.According to the reporter of the event, the ventilator was alarming for a patient circuit disconnect for a substantial time until the caregiver acknowledged the disconnect condition.The patient was moved to an intensive care unit following the event.The manufacturer's investigation is currently on-going.A follow-up report will be filed when the investigation is complete.
Additional Manufacturer Narrative
The device associated with this event was not returned to the manufacturer for evaluation.The hospital where the event occurred has determined the event was due to user error as the device alarms were not acknowledged in a timely manner.The manufacturer concludes the ventilator operated and alarmed as designed to indicate a patient circuit disconnect had occurred.

• 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: 6670119
• Report Number: 2518422-2017-01561
• Device Sequence Number: 13702754
• Product Code: CBK
• UDI-Device Identifier: 00606959033863
• UDI-Public: 00606959033863
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1032804
• Device Catalogue Number: 1032804
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR