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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 1032800
Medical Device Problem Code Circuit Failure (1089)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/14/2019
Type of Reportable Event Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for service.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, "service required" codes were found in the ventilator's downloaded error log.The device's system board was replaced to address the issue.The system board was returned to the manufacturer's quality assurance laboratory for further investigation.During the investigation, the cause of the system board failure was due to a failure of the central processing unit chip (u1) on the daughter board of the system board.
 
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Brand Name
TRILOGY 200
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
MDR Report Key8416605
Report Number2518422-2019-00432
Device Sequence Number1955005
Product Code CBK
UDI-Device Identifier00606959047419
UDI-Public00606959047419
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K093416
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/14/2019
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
Operator of Device Health Professional
Device Model Number1032800
Device Catalogue Number1032800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/14/2019
Initial Report FDA Received Date03/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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