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

Model Number 1054655

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cognitive Changes (2551)

Event Date 06/29/2016

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient became disconnected from a ventilator and now has a low level of consciousness.The reported event occurred on (b)(6) 2016.The following information is from the reporter of the event: the ventilator was being used non-invasively with a mask 24 hours per day.A review of the device's event log confirmed the device alarmed for a patient circuit disconnect for approximately 23 minutes before it was acknowledged.The caregiver went to the patient's room when another monitoring device that was in use began alarming.When the caregiver went to the patient's room, the patient was found to be in cardiac arrest.The patient was resuscitated, but now has a low level of consciousness.The ventilator was evaluated by the reporting facility and passed all testing, including alarm function.The reporting facility confirmed the device operates as intended and placed the device back into patient use.The ventilator will not be returned to the manufacturer for further evaluation.Based on this information, the manufacturer concludes the ventilator operated and alarmed as designed and that the event was caused by user error.

• 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: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 5840237
• MDR Text Key: 50942435
• Report Number: 2518422-2016-03308
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1054655
• Device Catalogue Number: 1054655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• 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): Life Threatening
• Patient Age: 25 YR