MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS BREATHING MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Device Emits Odor (1425)

Patient Problems Arrhythmia (1721); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Fever (1858); Headache (1880); Pneumonia (2011); Blurred Vision (2137); Sleep Dysfunction (2517); Cough (4457)

Event Date 03/09/2021

Event Type  Injury  

Event Description

I had been complaining about my breathing machine starting to make me feel bad.I became very restless every night with machine on.It began to become very difficult to sleep with machine on.Breathing became worse.Coughing increased.Mucus build up became worse in airway.Made several reports to doctors but to no avail.Going to emergency room more often.At one point i had a funny smell coming from within my machine.Kept machine as clean as i could.The more i complained to the doctor about wanting to stop the use of the machine.The more i was encouraged to continue on.I began to have badly blurred vision.Prescribed eye ware didn't help.Began to have chronic headaches.Increased chest pain and heart beat.Ended up being hospitalized for heart issues, pneumonia, high fever, and hallucinations.It was thought to be covid-19.All three covid test.Came back negative.I discontinued the usage of my breathing machine afterwards.This very day.All physicians i'm under.Insist i continue the use of my machine.Until this very day.I continue to suffer with chronic headaches.Blurry vision.Irregular heartbeats.Sugar levels off the chart.Vision is chronic.Godly pain has increased to a level that's hard to deal with.I'm under going mri x-ray and ct scans.On (b)(6) 2021 i'm having an mri brain test did for my headaches.I'm taking monthly injections for headaches.And will began botox injections for migraines.My issues with my machine began in 2019.Fda safety report id # (b)(4).

• Brand Name: PHILIPS BREATHING MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12203049
• MDR Text Key: 262934130
• Report Number: MW5102657
• Device Sequence Number: 1
• Product Code: BZD
• 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: 07/17/2021

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: 07/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 156