MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, TRILOGY EVO; CONTINUOUS, VENTILATOR, HOME USE

Device Problems Pressure Problem (3012); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hypoxia (1918)

Event Date 09/18/2021

Event Type  Injury  

Event Description

Likely due to home trilogy evo ventilator providing excess peep and pip above entered pressures (5-10 cm above set parameters), patient had been hypoxic at home, needed to go to ed and to be admitted.Changes on chest xray (larger cystic space) that may be due to ventilator malfunction.She now needs to be switched to a different type of vent for home- will require parent teaching, days in the hospital.Fda safety report id# (b)(4).

• Brand Name: TRILOGY EVO
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): PHILIPS / RESPIRONICS,
• MDR Report Key: 12513223
• MDR Text Key: 273091689
• Report Number: MW5104139
• Device Sequence Number: 1
• Product Code: NOU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 18 MO