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 Code	Death (1802)
Date of Event	09/08/2017
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient expired after becoming disconnected from a ventilator.The reported day of the event was (b)(6) 2017.According to the reporter of the event, the patient's wife checked on him at approximately 15:00:00 local time on (b)(6) 2017 and then returned to work.A relative visited the house and found the patient disconnected from the ventilator.The relative reconnected the patient and attempted to contact the wife.The patient was taken to a hospital where he expired.The ventilator was returned to the manufacturer for evaluation.The device passed all testing and was found to operate and alarm as designed.The ventilator's downloaded event logs were reviewed.The device maintains the event logs in non-volatile memory.An event, as logged by the device, includes every keypress, alarm or failure of the device to remain within specifications.There were no events logged related to device performance or device malfunctions.If a device malfunction occurred, the event logs would have contained entries related to the malfunction.On the reported day of the event, (b)(6) 2017, the ventilator began alarming for a low peak expiratory pressure condition at 17:45:21 local time followed by low peak inspiratory pressure and patient circuit disconnect alarms.The ventilator alarmed for 3458 seconds (approximately 57.6 minutes).This issue appears to have been corrected.At 18:59:43 on (b)(6) 2017, the ventilator began alarming for low peak expiratory pressure and low peak inspiratory pressure followed by a patient circuit disconnect alarm.The ventilator alarmed for 463 seconds (approximately 7.7 minutes) and the device was manually powered off at 19:07:26 local time.The ventilator was not powered on again until 23:29:22 on (b)(6) 2017.The manufacturer concludes the ventilator operated and alarmed as designed and did not cause or contribute to the reported event.The ventilator alarmed to alert the caregiver of the patient circuit disconnect which was not acknowledged in a timely manner.

• 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: 6916787
• Report Number: 2518422-2017-02259
• Device Sequence Number: 1444283
• 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
• Report Date (Section B): 09/24/2017

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: Patient Family Member or Friend
• Device Model Number: 1032804
• Device Catalogue Number: 1032804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2017
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 64 YR