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

Model Number 1054260

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 06/10/2019

Event Type  Death  

Event Description

The manufacturer received voluntary medwatch mw5092083.The caregiver claims the ventilator failed to alarm when ac power was disconnected from the device and when the device's batteries were depleted.The patient expired.The manufacturer contacted the durable medical supplier (dme) who filed the voluntary medwatch report.According to the dme, following this event the device was tested at his facility and at a third party service center.The ventilator passed all testing and was found to operate and alarm as designed.The dme reviewed the device's downloaded event logs and confirmed the device did alarm appropriately to alert the caregiver.The ventilator is not being returned to the manufacturer for further evaluation.

Manufacturer Narrative

The manufacturer received voluntary med watch mw5092336.The manufacturer has concluded voluntary med watch mw5092336 is for the same issue reported on mdr 2518422-2020-00162, for voluntary med watch mw5092083.

• Brand Name: TRILOGY 100
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 9621556
• MDR Text Key: 176041520
• Report Number: 2518422-2020-00162
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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
• Device Operator: Health Professional
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death