MAUDE Adverse Event Report: PHILLIPS / RESPIRONICS INC. TRILOGY EVO; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number TRILOGY EVO

Device Problems Defective Alarm (1014); Detachment of Device or Device Component (2907)

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

Event Date 03/31/2021

Event Type  malfunction  

Event Description

Patient disconnected from the trilogy evo and the vent did not alarm for circuit disconnect.Went to the patient's home and swapped out the vent.According to mom, no harm to the patient.No harm to patient.Returning the vent for further evaluation.Fda safety report id# (b)(4).

• Brand Name: TRILOGY EVO
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): PHILLIPS / RESPIRONICS INC. ; murrysville PA
• MDR Report Key: 11701995
• MDR Text Key: 246969116
• Report Number: MW5100912
• Device Sequence Number: 1
• Product Code: CBK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRILOGY EVO
• Device Catalogue Number: DS2110X11B
• 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 Age: 11 YR