MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. PHILLIPS RESPIRONICS SYSTEM ONE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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

Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Peeling (1999); Sore Throat (2396); Tissue Breakdown (2681); Cough (4457); Wheezing (4463)

Event Type  Injury  

Event Description

Over the past 4-5 yrs i have developed persistent throat irritation, chronic cough, wheezing, sob and fatigue, and over the past several weeks i have been waking up with severe headaches, much like i used to get before i began using a cpap.I have owned this present cpap unit for about 6 or 7 yrs, not sure of date.I have a phillips system one cpap machine.I also have over the past 2 yrs developed peeling sore lower lip not responsive to medical rx.I have never used any type of ozone cleaning.I have only used distilled h2o.I have been using the heated humidity setting routinely, usually set on 3-4.My family doctor, and my pulmonologist have not been able to solve these problems.I do not have asthma as far as i know, nor have i been told that i have asthma.I don't know what to do, i find it almost impossible to sleep without the cpap.I feel very sob and it causes severe headaches when i don't use the cpap.Fda safety report id #(b)(4).

• Brand Name: PHILLIPS RESPIRONICS SYSTEM ONE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 15744394
• MDR Text Key: 303299083
• Report Number: MW5113094
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 69 YR
• Patient Sex: Female