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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2021
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator was not displaying accurate values.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's machine flow sensor was replaced to address the issue.
 
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Brand Name
TRILOGY EVO
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge drive
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge drive
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin drive
new kensignton, PA 15068
7243349303
MDR Report Key11403887
MDR Text Key234408377
Report Number2518422-2021-00563
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 Non-Healthcare Professional
Type of Report Initial
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2021
Date Manufacturer Received02/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2020
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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