MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS DREAM STATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number AHX500H11

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Itching Sensation (1943); Pain (1994); Excessive Tear Production (2235); Sneezing (2251); Sleep Dysfunction (2517); Cough (4457)

Event Date 08/02/2021

Event Type  Injury  

Event Description

I have been using the philips respironics dreamstation c-pap device for five years this (b)(6).I was never notified that this device had been recalled; not from philips, not from my medical supply company ((b)(4)), not from my pulmonologist.I had seen an ad in a newspaper in (b)(6) about the recall and, obviously, stopped using this machine immediately.I have been experiencing devastating health problems now.I cannot sleep at night - i am itchy all over my body, head to toe, and sometimes will take 2-3 showers a day as i am in pain and try to stop this feeling.I have constant headaches, my nose is terribly itchy, i constantly sneeze, my eyes are itchy and tearing, i cough a lot and cannot seem to clear my throat and have mucus.I am so distressed that i was never notified of this very serious problem with the philips respironics dreamstation.It was supposed to help with my sleep apnea but now i am living in my own hell on earth.Since then, i have seen my internist, my pulmonologist, my endocrinologist and will see my ophthalmologist and i have an appt.With a new allergist/immunologist to try and get some help.No one knows what to do or what lies ahead for me in the future.I am so concerned about all of the devastating side effects and likely potential damage to my internal organs.All i have read from philips is that "no one has died" - yet.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAM STATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12985404
• MDR Text Key: 282299542
• Report Number: MW5105988
• 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: 12/08/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: AHX500H11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CALCIUM; CENTRUM SILVER; FLONASE SENSIMIST (WHEN NEEDED); OMEGA; ROSUVASTATIN ; SYNTHROID; TOPROL-XL ; VITAMIN C GUMMIES
• Patient Outcome(s): Disability
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White