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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problems Device-Device Incompatibility (2919); Patient Device Interaction Problem (4001)
Patient Problem Cough (4457)
Event Date 07/07/2021
Event Type  Injury  
Event Description
I have been using a philips c-pap dream machine for several years.In june, at my doctor's suggestion, i bought a so clean at machine.A month later i woke up with a bad cough that is almost constant and won't go away.Sometimes throughout the day, i cough so hard i almost vomit.I was perfectly healthy until this cough started.It's been going on for three and a half months now.I had chest xrays, ct scans, a bronchoscopy, blood tests, and the doctors can't figure out what is causing this cough.I have been on numerous antibiotics, inhalers, and steroids, none of which help.I never smoked and i was perfectly healthy before this, never even catching a cold from my schoolage grand kids who live with us.Nor has anyone i've been around caught this cough from me.Sudden debilitating cough.I have more tests than i can list all came back negative for anything specific.All the doctors told me was there is a white area in my lower left lung.The biopsy hasn't shown anything specific.Fda safety report id# (b)(4).
 
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Brand Name
PHILIPS DREAMSTATION
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS / RESPIRONICS, INC.
MDR Report Key12703903
MDR Text Key278790442
Report NumberMW5104965
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 10/23/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/26/2021
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
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
Patient Weight75
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