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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS INC. CPAP DREAMSTATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS / RESPIRONICS INC. CPAP DREAMSTATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Catalog Number DSX500HIIC
Patient Problems Dyspnea (1816); Pneumonia (2011); Cough (4457); Respiratory Insufficiency (4462)
Event Date 12/28/2023
Event Type  Injury  
Event Description
I found out by accident about the recall cpap machine.Never notified by anyone and made an appointment with a new doctor at salem chest due to mucus cough for months and difficulty breathing.When i went to the website for the new doctor, the first item was a page explaining the recall (which i never ever heard before).Went to philips site, entered the serial number of his cpap machine, and it was one of the recalled devices.Why were we not notified 2 years earlier? as time went on, my husband could not breath, and was taken to the emergency room, and admitted.After x-rays and numerous cultures; he was diagnosed with pneumonia of unknown organism.He came home new year's year of 2023, with oxygen.I contacted philips after registering his machine, told him how sick he was and was on oxygen, and they needed to send a new cpap immediately; they did in a day and a half.My husband has been on antibiotics twice, is on oxygen 24/7 except when he sleeps with his new cpap machine, and is going for another chest x-ray (b)(6) 2024.He will see his chest doctor in 2 weeks.My concern is not knowing what has caused his pneumonia and the doctors are not sure about life-long oxygen use.Philips requested the cpap machine back within a time frame.Thank you.
 
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Brand Name
CPAP DREAMSTATION
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS / RESPIRONICS INC.
MDR Report Key18661305
MDR Text Key334897396
Report NumberMW5151144
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 02/04/2024
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberDSX500HIIC
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/06/2024
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