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

Model Number 1054260

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

Patient Problem Respiratory Arrest (4461)

Event Date 08/13/2020

Event Type  Death  

Event Description

The manufacturer received information alleging a ventilator shut off while in patient use.The patient expired.A copy of the device's downloaded event log was forwarded to the manufacturer for review.A review of the device's event log show the device was powered on using battery power.The device was not connected to ac power.The event log shows the unit provided therapy per published specification while running on battery power.Additional review indicates the device alarmed appropriately to indicate a low battery condition, as designed.The device powered off after the battery charge was depleted.The unit was forwarded by the coroner's office to a factory authorized service center for evaluation.During evaluation by the factory authorized service center found, the device was found to operate and alarm to designed specifications.There were no issues noted with the ventilator during evaluation.

• 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 kensignton, PA 15068 ; 7243349303
• MDR Report Key: 10520923
• MDR Text Key: 206505779
• Report Number: 2518422-2020-02119
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959051942
• UDI-Public: 00606959051942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• 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
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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): Death