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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. DREAMSTATION AUTO BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number UDSX700S11F
Device Problem Compatibility Problem (2960)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2023
Event Type  malfunction  
Event Description
The manufacturer received information alleging the dreamstation auto bipap device filters are getting a white film on them.There was no report of patient harm or injury.Resolution: user stated that the filters are getting a white film on them, and need cleaned about every 16 hours.The device shuts off to very little pressure during the night and he wakes up to change the filters.They are using filters that are not philips brand and advised the patient that we will send 1 set of philips filters to see if that helps with this issue.Remediation tagged to send the patient philips brand filters, a reusable filter and a disposable filter.
 
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Brand Name
DREAMSTATION AUTO BIPAP
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 Key18094468
MDR Text Key327659652
Report Number2518422-2023-29368
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 Received11/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberUDSX700S11F
Device Catalogue NumberUDSX700S11F
Date Manufacturer Received10/09/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/25/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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