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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DREAMSTATION
Device Problems Degraded (1153); Nonstandard Device (1420); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
I have noticed the water getting blackish in the water chamber of my philips dreammachine cpap device but did not think it was a problem until i received the recall on my device.I have been using the soclean daily for sanitation and was also regularly cleaning the water chamber and replacing the filters as recommended.Philips is blaming the degradation of the sound abatement foam on the use of the soclean machine and soclean is blaming it on philips for using an inferior foam product.My doctor says that i still need to use a cpap, but my medical supply company says that there is a shortage of them and they are unable to provide one for me.Philips indicates that they are working on the problem but expect the process of replacing and/or repairing the devices will take 12 months.Fda safety report id # (b)(4).
 
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Brand Name
PHILIPS DREAMSTATION CPAP MACHINE
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS / RESPIRONICS, INC.
MDR Report Key12672495
MDR Text Key278081772
Report NumberMW5104813
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 10/18/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberDREAMSTATION
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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