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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1119867
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/11/2016
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, a "ventilator inoperative" code was found in the ventilator's downloaded error log.The device's blower motor was replaced to address the issue.
 
Additional Manufacturer Narrative
The manufacturer previously reported a failure of the blower motor.The blower motor was returned to the manufacturer's quality assurance laboratory for further investigation.During the investigation the root cause of the blower motor failing was due to seized bearings.
 
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Brand Name
TRILOGY 100
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
MDR Report Key5826023
Report Number2518422-2016-03156
Device Sequence Number13539543
Product Code CBK
UDI-Device Identifier00606959022058
UDI-Public00606959022058
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K083526
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Service and Testing Personnel
Type of Report Initial,Followup
Report Date (Section B) 07/11/2016
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 Number1119867
Device Catalogue Number1119867
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2016
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 07/11/2016
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date07/27/2016
Supplement Report FDA Received Date10/12/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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