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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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RESPIRONICS, INC. DREAMSTATION BIPAP PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DSX600H11
Device Problem Degraded (1153)
Patient Problems Pulmonary Dysfunction (2019); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464)
Event Date 01/04/2024
Event Type  Death  
Event Description
The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The patient has alleged nose irritation, respiratory tract irritation, lung disease, pulmonary fibrosis.The patient died.The device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
 
Manufacturer Narrative
H3 other text : device not returned to manufacturer.
 
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Brand Name
DREAMSTATION BIPAP PRO
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 Key19002571
MDR Text Key338880853
Report Number2518422-2024-15859
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 Other,Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDSX600H11
Device Catalogue NumberDSX600H11
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/04/2024
Initial Date FDA Received03/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/25/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1974-2021
Patient Sequence Number1
Patient Outcome(s) Death; Other;
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