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

Model Number 1054096

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/02/2020

Event Type  malfunction  

Event Description

The manufacturer received information alleging a patient expired while using a trilogy device.The patient was attached to the ventilator normally used while in his wheelchair.The device was not plugged into power.The device has not yet been returned to the manufacturer.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported a patient expired while using a trilogy device.The patient was attached to a ventilator normally used while in his wheelchair.The device was not plugged into power.The device was returned to the manufacturer's product investigation laboratory for investigation.No malfunction of the device was observed.On the date of the alleged event the device was not connected to ac power and was operating on battery power.The event log confirmed the device was operating on detachable and internal battery power on the day of the reported event, 01/02/2020.The device audibly alarmed appropriately as the detachable and then the internal batteries became depleted.There were keypresses to indicate these alarms were acknowledged.The ventilator continued to alarm until it shut down at 03:58.The manufacturer concludes the device operated and alarmed as designed while being used without an ac power source.

• Brand Name: TRILOGY 100
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge rd; murrysville, pa PA 15668
• Manufacturer Contact: adam price ; 312 alvin dr.; new kensington, pa, PA 15068 ; 7243349303
• MDR Report Key: 9621682
• MDR Text Key: 176044542
• Report Number: 2518422-2020-00167
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1054096
• Device Catalogue Number: 1054096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2010
• 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