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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC DREAMSTATION CPAP PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS NORTH AMERICA LLC DREAMSTATION CPAP PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number CAX400H12C
Device Problem Degraded (1153)
Patient Problem Burning Sensation (2146)
Event Date 10/27/2022
Event Type  malfunction  
Event Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging the patient is experiencing a burning nose.Patient also alleged visualization of black foam particles in the tubing.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
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Brand Name
DREAMSTATION CPAP PRO
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
1001 murry ridge lane
ste a
murrysville PA 15668
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
1001 murry ridge lane
ste a
murrysville PA 15668
Manufacturer Contact
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key16102514
MDR Text Key306703079
Report Number2518422-2023-00616
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K131982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCAX400H12C
Device Catalogue NumberCAX400H12C
Was Device Available for Evaluation? No
Date Manufacturer Received10/27/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/08/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberRES 88058
Patient Sequence Number1
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