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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. DREAMSTATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS RESPIRONICS, INC. DREAMSTATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problem Nonstandard Device (1420)
Patient Problems Bacterial Infection (1735); Chest Pain (1776); Fever (1858); Headache (1880); Sore Throat (2396); Taste Disorder (4422); Swollen Lymph Nodes/Glands (4432)
Event Date 07/02/2021
Event Type  Injury  
Event Description
Emergency room visit severe headache etc.After learning of the recall my doctor advised to call the equipment distributor in which our distributor advised they have been telling people to call their doctor.They advised to continue use but do not use ozone cleaner.I have only been using for a few months, but i have constant headaches excessive phlegm and have weird exhaust like smell and taste in the mornings.(b)(6) what the emergency room presumed as stomach virus.I had severe migraine like headache, 102.8 fever, chest pain and burning, ears throat hurting and burning, and swollen lymph nodes in my neck.Positive for staphylococcus.Fda safety reported id# (b)(4).
 
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Brand Name
DREAMSTATION
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS RESPIRONICS, INC.
MDR Report Key12142927
MDR Text Key260972414
Report NumberMW5102411
Device Sequence Number1
Product Code BZD
UDI-Device Identifier00606959022652
UDI-Public(01)00606959022652
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/26/2021
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 Age54 YR
Patient Weight109
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