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

Model Number	1054096
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)
Date of Event	11/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging that on (b)(6) 2019 a patient was found unresponsive and hypotensive on the floor while the ventilator was alarming for low minute ventilation and circuit disconnect.The patient was not disconnected from the circuit.The patient received manual resuscitation with a manual resuscitation bag, was suctioned and then regained consciousness.On (b)(6) 2019, the customer alleged that when the patient was connected to the same ventilator, the ventilator failed to immediately deliver breaths to the patient.The patient was then given breaths with a manual resuscitation bag until the ventilator started cycling.The patient was then placed back on the ventilator without incident.The device was returned to the manufacturer's product investigation laboratory for investigation.The manufacturer was unable to duplicate the reported events.The device maintains 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.The device passed all testing.The manufacturer concludes the ventilator operated and alarmed as designed and did not cause or contribute to the reported event.

• 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: 10600250
• Report Number: 2518422-2020-01997
• Device Sequence Number: 17101371
• Product Code: CBK
• UDI-Device Identifier: 00606959021662
• UDI-Public: 00606959021662
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: 1054096
• Device Catalogue Number: 1054096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 09/29/2020
• 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: Required Intervention
• Patient Age: 70 YR