MAUDE Adverse Event Report: PHILIPS RESPIRONICS / RESPIRONICS INC. PHILIPS TRILOGY 100; CONTINUOUS, VENTILATOR, HOME USE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Blister (4537); Swelling/ Edema (4577)

Event Date 02/18/2023

Event Type  Injury  

Event Description

For the past 2 years, i develop nose blister like sores.I treat them with antibiotic ointment.I have also developed an ongoing sinus infection.On this specific date, i developed a different type of sore.In my nose.It grew and spread.I was taken to the emergency department.I refused to be admitted to the hospital because i needed to make arrangements for my children.I followed up and i am still getting treatment outside of the hospital.My physician is pressing to find me a replacement machine.My current philips trilogy 100 has been in use for six and a half years.I have used it every day for 6+ years.My doctor can send the testing results.My body needs to be tested for toxic chemicals.I took pictures of the beginning of the swelling inside my nose on the day it started, then took pictures as it spread.

• Brand Name: PHILIPS TRILOGY 100
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS INC.
• MDR Report Key: 16461418
• MDR Text Key: 310586595
• Report Number: MW5115321
• 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
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2023
• Patient Sequence Number: 1
• Treatment: OXYGEN; PRESCRIPTION MEDICATION, PLEASE CONTACT MY PHYSICIAN FOR MORE INFO.
• Patient Outcome(s): Other; Life Threatening; Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 66 KG