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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY BIPAP; CONTINUOUS, VENTILATOR, HOME USE
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RESPIRONICS, INC. TRILOGY BIPAP; CONTINUOUS, VENTILATOR, HOME USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pneumonia (2011); Respiratory Failure (2484)
Event Date 10/07/2021
Event Type  Death  
Event Description
The manufacturer received information through mw5148236 alleging while using a ventilator the patient kept getting pneumonia and died from respiratory failure.The information indicates the patient was stopped smoking 30 years ago while passed away.There is no allegation the ventilator malfunctioned or failed to deliver therapy as designed.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Manufacturer Narrative
H3 other text : not returned to the manufacturer.
 
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Brand Name
TRILOGY BIPAP
Type of Device
CONTINUOUS, VENTILATOR, HOME USE
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
jenn canada
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key19069434
MDR Text Key339670794
Report Number2518422-2024-18283
Device Sequence Number1
Product Code NOU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No
Date Manufacturer Received11/21/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization;
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