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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1040005
Device Problem Failure to Recalibrate (1517)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Event Description
A ventilator was returned to a third party service center for evaluation.The device was not in patient use.During the evaluation of the device at a third party service center, the device failed a step during testing.The device's active exhalation control module was replaced to address the issue.
 
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Brand Name
TRILOGY 200
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 Key11736235
MDR Text Key247666406
Report Number2518422-2021-01146
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959022737
UDI-Public00606959022737
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093416
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1040005
Device Catalogue Number1040005
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/15/2021
Initial Date FDA Received04/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2013
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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