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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DSX520H11C
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2023
Event Type  malfunction  
Event Description
The manufacturer received information alleging the dreamstation2 advanced auto cpap device paint inside the humidifier tank is peeling.There was no report of patient harm or injury.Resolution to customer: patient has original tank.They were informed that the tank should be replaced every 6 months.They stated something was peeling from the inside of the tank.They were asked how they clean, and they stated that they use water a vinegar once a week.Patient was educated on cleaning instructions on entire device.Told to contact the dme for a new water chamber and follow proper cleaning.Reach back out for any issues.
 
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Brand Name
DS2ADV 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 Key18106629
MDR Text Key328500861
Report Number2518422-2023-29751
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200480
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 Received11/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDSX520H11C
Device Catalogue NumberDSX520H11C
Was Device Available for Evaluation? No
Date Manufacturer Received10/11/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/03/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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