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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. DREAMSTATION CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS RESPIRONICS, INC. DREAMSTATION CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number REDSXH
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Fatigue (1849); Fever (1858); Headache (1880); Unspecified Infection (1930); Dizziness (2194); Reaction to Medicinal Component of Device (4574)
Event Date 12/17/2019
Event Type  Injury  
Event Description
I experienced trouble breathing, fever, headaches, dizziness, nasal congestion, postnasal drip, and fatigue.This sent me to urgent care, where i was given a breathing treatment and prescribed antibiotics, an inhaler, and flonase.When my symptoms came back, i was given an mri where they found infectious fluid in my skull cavity.I was treated with antibiotics twice for this same condition because it came back and doctors do not know why.It is coming back again.I had also experienced a popping and pulling sensation in my left ear that was caused by a mucosal thickening / inflammatory reaction of my left maxillary sinus.This was also found in my mri results.This stems from either trauma, infection, chemical agents, allergies or neoplasm.
 
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Brand Name
DREAMSTATION CPAP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS RESPIRONICS, INC.
MDR Report Key12438530
MDR Text Key270519389
Report NumberMW5103744
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 08/26/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberREDSXH
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age50 YR
Patient Weight144
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