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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 Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2024
Event Type  malfunction  
Manufacturer Narrative
H3 other text : the device has been received by the third-party service center.Analysis is in process.
 
Event Description
The manufacturer was contacted regarding a cpap device.The patient alleges that both filters continue to turn black even after switching them out.No clinical or medical information is specified.The manufacturer received the device and forwarded it to a third-party service center for analysis, which is in process.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
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 Key18931770
MDR Text Key338067103
Report Number2518422-2024-14143
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 Received03/19/2024
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2024
Date Manufacturer Received01/05/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/15/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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