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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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RESPIRONICS, INC. DREAMSTATION 2 AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problems Moisture Damage (1405); Nonstandard Device (1420); Product Quality Problem (1506); Noise, Audible (3273); Patient Device Interaction Problem (4001)
Patient Problems Fatigue (1849); Sleep Dysfunction (2517)
Event Date 11/01/2021
Event Type  Injury  
Event Description
Patient called to report an issue with her replacement cpap device she received after her first one was recalled by philips respironics.Patient stated her first dreamstation cpap device was recalled, and she received a replacement dreamstation 2 auto cpap device about two months ago.Patient stated after a month of using the new device, she woke in the middle of the night with water inside the mask where her nose and mouth are.Patient said it then happened a second time where she woke up to water in the mask.Patient also stated the water reservoir makes a lot of noise and the noise comes through the mask.Patient stated she is very tired, and this has disrupted her sleep, she wakes in the middle of the night worrying she is going to choke on water getting into her mask.Patient stated she tried calling philips respironics, but she just gets put on hold and hung up on.
 
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Brand Name
DREAMSTATION 2 AUTO CPAP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS, INC.
MDR Report Key13059942
MDR Text Key282646028
Report NumberMW5106205
Device Sequence Number2
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 12/20/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/20/2021
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age63 YR
Patient SexFemale
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