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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION AUTOLEVEL BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION AUTOLEVEL BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Asthma (1726); Conjunctivitis (1784); Cough (4457); Unspecified Respiratory Problem (4464)
Event Type  Injury  
Event Description
I have had recurring conjunctivitis, device-induced asthma, sinus and upper respiratory infections, cough, and numerous sicknesses caused by the philips dreamstation autolevel bipap.Fda safety report id # (b)(4).
 
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Brand Name
PHILIPS DREAMSTATION AUTOLEVEL BIPAP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS / RESPIRONICS, INC.
MDR Report Key12835609
MDR Text Key281027710
Report NumberMW5105427
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/17/2021
Patient Sequence Number1
Treatment
CYMBALTA ; OMEPRAZOLE ; TOPRIL XL ; XANAX; ZOLOFT
Patient Outcome(s) Life Threatening; Disability;
Patient Age29 YR
Patient SexMale
Patient Weight218 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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