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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. REP DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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RESPIRONICS, INC. REP DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number UDSX500S11F
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2023
Event Type  malfunction  
Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
 
Event Description
The manufacturer was contacted in reference to a rep dream station auto cpap device.The manufacturer received information alleging black particles in the filter and has an issue turning the device on.The patient also alleged that her allergies and sinuses seem a bit off.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.
 
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Brand Name
REP 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 Key18552450
MDR Text Key333360343
Report Number2518422-2024-03684
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 Received01/22/2024
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 Received05/09/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/21/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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