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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. TRILOGY 100 VENTILATOR; CONTINUOUS, VENTILATOR, HOME USE
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PHILIPS / RESPIRONICS, INC. TRILOGY 100 VENTILATOR; CONTINUOUS, VENTILATOR, HOME USE Back to Search Results
Model Number 1054260B
Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682); Gas/Air Leak (2946); Material Integrity Problem (2978)
Patient Problems Eye Injury (1845); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Event Date 06/01/2017
Event Type  Injury  
Event Description
My son uses the trilogy 100 ventilator.They have been recalled which we still have not been notified except i saw it in an article.He had a horrible eye reaction in (b)(6) of 2017.Several ophthalmologist have seen him saying it is a allergic reaction and we need to fix the problem right way.He is on an eye drop so his eyes do not swell shut that will hurt his corneas over time.The condition is worsening.He is allergic to all materials except cotton.The interior foam in the trilogy is made of polyurethane foam that is desecrating which is causing off gassing.We have been told that there are no other ventilators so no ones can be replaced even though he is having bad physical reactions.Is the a time limit on the replacement? was the company or our dme company suppose to tell us? what can i do in the mean time to help him? thank you very much.(b)(6).
 
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Brand Name
TRILOGY 100 VENTILATOR
Type of Device
CONTINUOUS, VENTILATOR, HOME USE
Manufacturer (Section D)
PHILIPS / RESPIRONICS, INC.
MDR Report Key12287524
MDR Text Key265597593
Report NumberMW5103044
Device Sequence Number1
Product Code NOU
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1054260B
Device Catalogue NumberREV00
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age33 YR
Patient Weight68
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