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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 1032802
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/21/2016
Type of Reportable Event Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer's service center for evaluation.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, a "service required" code was found in the ventilator's downloaded error log.The device's battery connector cable was replaced to address the issue.
 
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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 Key5574229
Report Number2518422-2016-01656
Device Sequence Number258366
Product Code CBK
UDI-Device Identifier00606959022690
UDI-Public606959022690
Combination Product (Y/N)N
Initial Reporter CountryGM
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) 03/21/2016
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 Number1032802
Device Catalogue Number1032802
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/21/2016
Initial Report FDA Received Date04/13/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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