MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1040005

Device Problems Degraded (1153); Microbial Contamination of Device (2303)

Patient Problems Headache (1880); Pyrosis/Heartburn (1883); Sore Throat (2396); Respiratory Tract Infection (2420); Abdominal Distention (2601); Wheezing (4463); Unspecified Respiratory Problem (4464)

Event Date 01/05/2022

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging headaches, nasal congestion, wheezing in throat, heartburn, swollen stomach and nasal/throat irritation or soreness.There was no report of serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer was previously contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no report of serious patient harm or injury.Section h9 was reported incorrectly in previous report which is now been corrected in this follow-up report.

Manufacturer Narrative

The manufacturer previously reported an issue related to ventilator's device sound abatement foam.There was no report of patient harm or injury.The patient also alleged headaches, nasal congestion, wheezing in throat, heartburn, swollen stomach and nasal/throat irritation or soreness.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected the external part of the device and found few particles of external origin in bacteria filter after the unit operation and foreign dust particles of external environemental origin on blower bellows (inner and outer) and impeller curved blades.Presence of foreign dust particles was confirmed inside the blower transition tubing.The manufacturer visually inspected the device internally and could not find any black foam particulate inside the unit including flow path assembly however, the foam appears browning, worn and time to change.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there were few particles of external origin in bacteria filter after the unit operation and foreign dust particles of external environemental origin on blower bellows and could not find any black foam particulate inside the unit including flow path assembly but the foam appears browning, worn and time to change.

• Brand Name: TRILOGY 200
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15475878
• MDR Text Key: 305526020
• Report Number: 2518422-2022-82442
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1040005
• Device Catalogue Number: 1040005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 01/05/2022; 04/24/2023
• Supplement Dates FDA Received: 09/24/2022; 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88071
• Patient Sequence Number: 1