MAUDE Adverse Event Report: RESPIRONICS INC. TRILOGY 100; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number MO40818

Device Problem Nonstandard Device (1420)

Patient Problems Headache (1880); Unspecified Respiratory Problem (4464); Eye Pain (4467); Skin Inflammation/ Irritation (4545)

Event Date 08/14/2021

Event Type  Injury  

Event Description

Since still using recalled ventilator, i am experiencing runny nose, headaches, eye and skin irritations yet philips cannot give me a date when i will get replacement and i'm still having to pay monthly to apria for a recalled ventilator which is my lifeline.It is long overdue, and my health already keeps me bedridden.I suffer from als this machine is vital for me.I'm tired of being put on hold to get this replaced.Every time my caregiver calls to get update all they say every time oh we will put her on the priority list well each time caregiver gets told them do, they really have priority list and am i really on it.? this is unprofessional and my health should not suffer due to their lack of fixing the problem.I truly feel they are just waiting for me to die so they don't have to replace this.When will this get replaced? fda safety report id # (b)(4).

• Brand Name: TRILOGY 100
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 14976507
• MDR Text Key: 295717772
• Report Number: MW5110774
• Device Sequence Number: 1
• Product Code: BZD
• 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
• Type of Report: Initial
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2016
• Device Model Number: MO40818
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: OXYCODONE 5 MG ATIVAN VENTILATOR, TRACHEA, RESPIRATOR, NEBULIZER MACHINE.
• Patient Outcome(s): Disability
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White