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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. REM DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. REM DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number UDSX500S11F
Device Problem Mechanical Problem (1384)
Patient Problem Dyspnea (1816)
Event Date 12/20/2023
Event Type  malfunction  
Event Description
The manufacturer was contacted in reference to a rep dreamstation auto cpap.The manufacturer received information alleging that the device starts to slow down in the middle of the night.The air that comes out is too low and causes him to not be able to breathe.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.
 
Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
 
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Brand Name
REM DREAMSTATION AUTO CPAP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key18545935
MDR Text Key333276112
Report Number2518422-2024-03571
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberUDSX500S11F
Device Catalogue NumberUDSX500S11F
Was Device Available for Evaluation? No
Date Manufacturer Received12/20/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/27/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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