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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS RESPIRONICS / RESPIRONICS, INC. BI-PAP 60 SERIES SYSTEM ONE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS RESPIRONICS / RESPIRONICS, INC. BI-PAP 60 SERIES SYSTEM ONE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Patient Problems Dyspnea (1816); Fatigue (1849); Cough (4457); Nodule (4551)
Event Date 02/01/2020
Event Type  Injury  
Event Description
Ongoing past three years.Progressively getting worse.Coughing day and night, thick mucous from lungs and sinuses.Fatigue and shortness.Of breath, lung nodules, allergy shots not working.Meds not helping.Multiple courses on steroids and antibiotics.Was not informed that i am using recalled bi-pap until yesterday (b)(6)2024 when a friend heard it on the news in pgh.I registered recalled bi-pap on philips respironics web site.Said my bi-pap is greater than 5 years old and out of warranty and probably not eligible for a replacement.Don't understand why company did not tell me i was still using device.And i lived in (b)(6) pa and did two clinical trials for them.Philips system one 60 series.I have used for about 10 years; (b)(6) 2015".
 
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Brand Name
BI-PAP 60 SERIES SYSTEM ONE
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS RESPIRONICS / RESPIRONICS, INC.
MDR Report Key18660708
MDR Text Key334896704
Report NumberMW5151125
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 02/02/2024
1 Device was Involved in the Event
Date FDA Received02/06/2024
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
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