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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. TRILOGY EVO; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number DS2110X11B
Device Problem Device Emits Odor (1425)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2023
Event Type  malfunction  
Manufacturer Narrative
Not returned to manufacturer.
 
Event Description
The manufacturer received information alleging a ventilator had a burning smell.There was no harm or injury reported.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.
 
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Brand Name
TRILOGY EVO
Type of Device
VENTILATOR, CONTINUOUS, FACILITY 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
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key16767203
MDR Text Key313561750
Report Number2518422-2023-08749
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959051942
UDI-Public00606959051942
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 Received04/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDS2110X11B
Device Catalogue NumberDS2110X11B
Was Device Available for Evaluation? No
Date Manufacturer Received03/20/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/15/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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