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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS/ RESPIRONICS INC. DREAMSTATION AUTO CPAP HUM DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS/ RESPIRONICS INC. DREAMSTATION AUTO CPAP HUM DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DSX500H11
Device Problem Product Quality Problem (1506)
Patient Problems Irritability (2421); Unspecified Tissue Injury (4559)
Event Date 03/25/2020
Event Type  Injury  
Event Description
About 30 - 45 days after beginning use of philips dreamstation cpap machine a sore developed in my nostril.I would use saline gel and antibiotic ointment on it.It would heal briefly but it would come right back in a day or two.On (b)(6) 2021 when this cpap machine was recalled i went to my md and purchase a new dreamstation 2 that was not part of the recall.The sore in my nostril has healed and has not returned.I always clean and care for my machine, hose, and mask as advised.I did not initially link the sore to the cpap.I had thought it was all the kn95 mask i have been wearing as a healthcare worker causing me to have more sinus drainage.However, i am still a healthcare worker and i wear kn95 mask each day at work still.The only difference now is the new cpap machine.Thus, it is my belief that the particles or fumes from the sound abatement foam in the original (now recalled) philips dreamstation has been causing this long term irritation of my nasal passages and the sore in my nostril was the most prominent result of this irritation.Fda safety report id# (b)(4).
 
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Brand Name
DREAMSTATION AUTO CPAP HUM DOM
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS/ RESPIRONICS INC.
MDR Report Key12050361
MDR Text Key258211591
Report NumberMW5102051
Device Sequence Number1
Product Code BZD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDSX500H11
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age56 YR
Patient Weight63
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