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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATION CPAP DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS / RESPIRONICS, INC. DREAMSTATION CPAP DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DSX500T11C
Device Problems Nonstandard Device (1420); Patient Device Interaction Problem (4001)
Patient Problems Eye Injury (1845); Fatigue (1849); Headache (1880); Inflammation (1932); Cough (4457); Unspecified Kidney or Urinary Problem (4503); Skin Inflammation/ Irritation (4545)
Event Date 07/31/2021
Event Type  Injury  
Event Description
I begain experiencing excruciating headaches, recurrent sinus infections, chest pressure, cough, eye and skin irritation, bladder and kidney issues and fatigue.I underwent a sleep study in 2020 and was prescribed to use a dreamstation cpap machine by my doctor through philips respironics.I received a recall notice in the mail for the machine.I stopped using the machine while sleeping once i received this notice in the mail.I followed the instructions on the recall notice to register the device online as of (b)(6) 2021.I have not been feeling well for several months and realized most of the symptoms on the recall notice are similar to what i am experiencing health wise.
 
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Brand Name
DREAMSTATION CPAP DEVICE
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS / RESPIRONICS, INC.
MDR Report Key12697018
MDR Text Key278572896
Report NumberMW5104932
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 12/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberDSX500T11C
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age62 YR
Patient Weight79
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