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U.S. Department of Health and Human Services

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

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RESPIRONICS, INC. PHILIPS RESPIRONICS DREAM STATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DSXHCP (WATER TANK)
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).
 
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Brand Name
PHILIPS RESPIRONICS DREAM STATION AUTO CPAP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS, INC.
MDR Report Key12985404
MDR Text Key282299542
Report NumberMW5105988
Device Sequence Number2
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberDSXHCP (WATER TANK)
Patient Sequence Number1
Treatment
CALCIUM; CENTRUM SILVER; FLONASE SENSIMIST (WHEN NEEDED); OMEGA; ROSUVASTATIN ; SYNTHROID; TOPROL-XL ; VITAMIN C GUMMIES
Patient Outcome(s) Disability;
Patient SexFemale
Patient Weight63 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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