MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO; CONTINUOUS, VENTILATOR, HOME USE

Model Number 2110X11

Device Problems Device Alarm System (1012); Particulates (1451); Tidal Volume Fluctuations (1634); Key or Button Unresponsive/not Working (4063)

Patient Problems Aspiration/Inhalation (1725); Pain (1994); Diaphoresis (2452); Abdominal Distention (2601)

Event Date 12/30/2021

Event Type  Death  

Event Description

The triology evo model # 2110x11, serial# (b)(4) continuous ventilator was used on my dad to come home from the hospital to continue care home on (b)(6) 2021.The alarms went off many times over the few days he was home, my dad kept requesting to have ett tube and vent.Removed from the rn who came and myself.No one would remove it, i was not trained how.I called for help from (b)(6) medical supply company who supplied ventilator everyday since the ventilator continuously was having major alarms even on the day he arrived home on it (b)(6) 2021.I called medical staffing assigned to my dad multiple times a day and 911 over 5 times before his death on (b)(6) 2022.On (b)(6) his ventilator went off continuously starting at 330am.My mother was sitting with my dad while i rested for my next shift to take care of dad.I woke up and ran in his room about 4am.I took over for my frazzled mother and tried suctioning, playing with hoses, and shifting my dad differently in the bed and nothing would stop alarms.The alarms kept getting louder and the machine was giving my dad more air then was suppose to my dad started holding his sides in pain, it seemed to be giving him more air then the settings of 20 breaths a minute.I called for help from (b)(6) and heartland home care direct help lines multiple times over the 5 days since machine seem to keep having alarms go off and my dad was so uncomfortable.They did not answer the phone or respond to my multiple attempts for desperate need of help with the machine from (b)(6) 2021 to (b)(6) 2022.On (b)(6) 2022 after several attempts that morning to get help.(b)(6) answered the phone at (b)(6) and said she was respiratory specialist.She tried to walk me through all the steps i had already tried from reading the manual.By this time the alarm and machine was malfunction for almost 1.5 hrs and (b)(6) offered to come to home to see if she could fix it.She arrived 45 mins later and alarms still going off like crazy.My mother, father, and myself were all really scared at this point and we were hopeful (b)(6) could fix ventilator.My dad was getting extremely exhausted from the machine delivering too many breaths a minute leaving little time to exhale.It was set for 20 breaths a minute and was delivery off the charts breaths.My dad stomach look like balloon being blown up continually moving in and out extremely fast.He was being shook continuously for all the extra air.He kept holding his sides.(b)(6) tinkered with the machine while reading the manual with no luck on shutting off alarms or fixing the air issue.After a couple attempts to clear what she thought was a mucus plug.She gave up and told us to call 911.The 911 team arrived and all tried to fix the machine or move him.They only offered to bring him back to hospital.The machine kept blowing up my dad and alarms continued.Now we have 5 medical trained individuals throwing up hands saying they don't know.The 911 team called in a special care team 911 to help with ventilator since they were stumped.This has now been almost 4 hours my dad has been being blown up like a balloon and extremely exhausted.You could see in my dad's eyes he was petrified in fear, he was sweating extensively.The care team came in and said something is wrong with machine and the settings are way to high.After extensive check over saying it's the machine they removed the evo and put them on care team's vent to transport to the hospital.After he was taken to ambulance, (b)(6) told my mother to call an attorney since something was wrong with the machine.I took pictures, vent had 50 pages of alarms that morning and the humidifier has particle all in the water.Autopsy proved it covered my dad's lungs.Please get justice for my dad's untimely death and save others from same agony.Fda safety report id# (b)(4).

• Brand Name: TRILOGY EVO
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 14374344
• MDR Text Key: 291602640
• Report Number: MW5109639
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2110X11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: VITAMIN C
• Patient Outcome(s): Hospitalization; Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White