MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. TRILOGY 100 HOME VENTILATOR; CONTINUOUS, VENTILATOR, HOME USE

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2022

Event Type  malfunction  

Event Description

Rt inquired with resmed manufacturer on regarding the lack of a ventilator setting and discovered that ventilator was manufactured overseas and not fda approved.This spurred efl(equipped for life) to investigate additional ventilators purchased through secondary vendor.Forty-one patients impacted with non-fda ventilators in the home; twelve pediatric patients and 29 adult patients.All used astral 150 ventilators in question inspected upon purchase, in-between patient use, and routinely during patient home visits for functionality to include proper operations of alarms and operational modes prescribed by physician.No patient safety issues related to the use of these ventilators in the home setting since this equipment has been deployed.Plan has been developed and in process for switching all patients to a fda approved ventilators.In june of 2021, philips respironics announced a significant recall on their trilogy100 home ventilators.Equipped for life had 120 of these ventilators in stock that required replacement.In august-september of 2021, first replacement purchase composed of purchases of 30 new astral 150 ventilators direct from the manufacturer, resmed, and 30 used astral 150 ventilators from quality biomedical, a company that is an authorized resmed repair and pm company that we use to service our equipment and rent equipment for short-term use.The second capital expenditure was processed in april-may of 2022 for an additional 30 used astral 150 ventilators from quality biomedical, and 40 new evo ventilators direct from manufacturer, philips respironics.Due to both the heightened use of ventilators during the pandemic and the recall of philips trilogy100 ventilators, the market for home ventilators has been very strained forcing us to utilize the secondary market for equipment to meet our volume needs, hence the purchase of the used ventilators as part of these two capital expenditures.

• Brand Name: TRILOGY 100 HOME VENTILATOR
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 16323561
• MDR Text Key: 309179894
• Report Number: MW5114767
• Device Sequence Number: 2
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/03/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose