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

Device Problems Degraded (1153); Nonstandard Device (1420)

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

Event Type  Injury  

Event Description

On (b)(6) home ventilator issues with standard and back up vents.After multiple changes of tubing and filters able to finally stabilize on standard vent.Recently learned of philips recall.Looking back at incident reports there had been one report in (b)(6) of discolored water particles in humidification chamber resolved with changing humidification chamber and sterile inhalation bag.At that time, we were unaware of the ventilator recall.Standard and portable ventilators were switched out by vendor (b)(6) 2023 to newer versions of the recalled ventilators.Reference report: mw5117078.

• Brand Name: TRILOGY 100 HOME VENTILATOR
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 16831708
• MDR Text Key: 314311938
• Report Number: MW5117079
• Device Sequence Number: 1
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VENTILATOR TUBING AND FILTERS.
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male