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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILLIPS / RESPIRONICS, INC. PHILLIPS DREAMSTATION DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILLIPS / RESPIRONICS, INC. PHILLIPS DREAMSTATION DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DSX500S11
Patient Problem Sleep Dysfunction (2517)
Event Date 01/27/2024
Event Type  malfunction  
Event Description
I have a phillips dream station auto continuous positive airway pressure dom that was part of the recall.They sent me a refurbished machine of the same model (s/n (b)(6)).Since getting the replacement i have not being sleeping well with it.Last saturday i woke up in the middle of the night because i could not get enough air.When i check my machine, it was back at the ramp pressure of 4 which is way lower that it should be.I got curios and started to compare my second machine (a dream station 2) against the refurbished and noticed that the average pressure on the refurbished is consistently lower than the one in the new ds2 machine.I wake up a lot when i used the refurbished device and although i cannot definitely state that the machine is fluctuating pressure over the night, i believe that is the case because i am frequently grasping for air.There is something wrong with the refurbished device, because the prescription is the same but they effectiveness is different or lower on it.Reference report: mw5151100.
 
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Brand Name
PHILLIPS DREAMSTATION DOM
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILLIPS / RESPIRONICS, INC.
MDR Report Key18658799
MDR Text Key334988127
Report NumberMW5151099
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? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDSX500S11
Was Device Available for Evaluation? Yes
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