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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 1032804
Medical Device Problem Code Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/16/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
There were no repairs done to the device.The device scrapped per the customer request.
 
Event or Problem Description
A ventilator was returned to the manufacturer for service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the device failed test steps during testing related to the sensor board.
 
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Brand Name
TRILOGY 200
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
MDR Report Key7552624
Report Number2518422-2018-01261
Device Sequence Number13503994
Product Code CBK
UDI-Device Identifier00606959033863
UDI-Public00606959033863
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K093416
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Service and Testing Personnel
Type of Report Initial
Report Date (Section B) 05/16/2018
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 Number1032804
Device Catalogue Number1032804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/16/2018
Initial Report FDA Received Date05/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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