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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. HOME VENTILATOR TRILOGY 100; CONTINUOUS, VENTILATOR, HOME USE
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PHILIPS RESPIRONICS, INC. HOME VENTILATOR TRILOGY 100; CONTINUOUS, VENTILATOR, HOME USE Back to Search Results
Model Number 73C-BK
Device Problem Nonstandard Device (1420)
Patient Problems Unspecified Infection (1930); Loss of consciousness (2418)
Event Date 01/02/2022
Event Type  Death  
Event Description
The legal representative for the family states the following: 2 yr old (b)(6) was on a ventilator with underlying health issues.The 2 yr old was on (b)(6) due to his condition.The pediatrician recommended the parents feed him the similac elecare product through a permanent feeding tube.On (b)(6) 2021, (b)(6) began to develop infections and was treated by his pediatrician.(b)(6) was prescribed a round of antibiotics and per the information provided (b)(6) began to feel better.Once the antibiotics were complete, (b)(6) developed an infection again and the pediatrician provided another round of antibiotics and while on antibiotics he began feeling better.Then on the morning of (b)(6) 2022, (b)(6) was found unresponsive in his crib and 911 was called.(b)(6) was declared dead at the hospital.On (b)(6) 2022, (b)(6) mom received a voicemail from (b)(6) advising that the product that was delivered was subject to recall.Also, the (b)(6) took possession of (b)(6) body and performed an autopsy, the results are not yet available.Currently, the families legal rep states, "the parents preserved all elecare jr, and delivered to me, their attorney, for investigation".
 
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Brand Name
HOME VENTILATOR TRILOGY 100
Type of Device
CONTINUOUS, VENTILATOR, HOME USE
Manufacturer (Section D)
PHILIPS RESPIRONICS, INC.
1001 murry ridge ln
murrysville PA 15668 8517
MDR Report Key15885516
MDR Text Key304521015
Report NumberMW5113520
Device Sequence Number1
Product Code NOU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Attorney
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model Number73C-BK
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/30/2022
Patient Sequence Number1
Treatment
HEART RATE MONITOR
Patient Outcome(s) Death;
Patient Age2 YR
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