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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 Problems Contamination (1120); Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/29/2024
Event Type  malfunction  
Event Description
A ventilator was returned to the manufacturer for investigation.There was no harm or injury reported.During the evaluation of the device at the manufacturer's product investigation lab (pil), a "service required" code was found in the ventilator's downloaded error log.The device also failed a test step during testing.The device was disassembled and contamination was found inside the flow sensor.
 
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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 Key18839364
MDR Text Key336961278
Report Number2518422-2024-11771
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 Company Representative
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberDS2110X11B
Device Catalogue NumberDS2110X11B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/29/2024
Date Manufacturer Received02/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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