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U.S. Department of Health and Human Services

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

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PHILLIPS / RESPIRONICS INC. TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
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).

 
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Brand NameTRILOGY EVO
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
PHILLIPS / RESPIRONICS INC.
murrysville PA
MDR Report Key11701995
MDR Text Key246969116
Report NumberMW5100912
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received04/20/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberTRILOGY EVO
Device Catalogue NumberDS2110X11B
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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