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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 1054096
Medical Device Problem Code Device Operational Issue (2914)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/24/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device has been evaluated but not repaired.The estimate was rejected and the device scrapped per the customer request.
 
Event or Problem Description
A ventilator was returned to the manufacturer for routine preventive maintenance.There was no allegation of device malfunction.The device was not in patient use.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 sensor board was replaced to address the issue.
 
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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 Key6871675
Report Number2518422-2017-02108
Device Sequence Number1183265
Product Code CBK
UDI-Device Identifier00606959026261
UDI-Public00606959026261
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K083526
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) 08/24/2017
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 Number1054096
Device Catalogue Number1054096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/24/2017
Initial Report FDA Received Date09/18/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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