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

Model Number 1054097

Device Problem Use of Device Problem (1670)

Patient Problem Respiratory Distress (2045)

Event Date 11/24/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator failed to alarm for a patient disconnect.The patient was taken to a hospital.No permanent injury was reported.The ventilator was being used with a 15 millimeter circuit and a heated humidifier.Following the event, the patient's physician activated the low minute ventilation alarm.The ventilator is currently in use with the patient.Any accessory that could cause increased resistance within the patient circuit can result in the patient circuit disconnect alarm not functioning in the event of a patient circuit disconnect.Other alarms, such as low tidal volume, low minute volume, low respiratory rate and apnea should be set appropriately.These alarms appear to have been disabled at the time of the event.Following the event, the patient's physician activated the low minute ventilation alarm.Device labeling states the following: "prior to placing a patient on the ventilator, a clinical assessment should be performed to determine: ··the device alarm settings ··needed alternative ventilation equipment ··if an alternative monitor (i.E.An alarming pulse oximeter or respiratory monitor) should be used for ventilator dependent patients, do not rely on any single alarm to detect a circuit disconnect condition.The low tidal volume, low minute ventilation, low respiratory rate, and apnea alarms should be used in conjunction with the circuit disconnect and low peak inspiratory pressure alarms.Test the operation of the circuit disconnect function daily and whenever a change is made to the patient circuit.An increase in circuit resistance can prevent proper operation of some alarms.Speaking valves, heat moisture exchangers (hmes), and filters create additional circuit resistance and may affect the performance of alarms chosen for circuit disconnect protection".

• Brand Name: TRILOGY 100
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15668
• MDR Report Key: 9438989
• MDR Text Key: 169881966
• Report Number: 2518422-2019-02880
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1054097
• Device Catalogue Number: 1054097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other