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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 1054260
Medical Device Problem Code Device Operational Issue (2914)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device has been evaluated but the components have not been replaced pending customer approval of estimate.
 
Event or Problem Description
A ventilator was returned to the manufacturer for routine preventative 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 failure of the device to power on was observed.The device's system board, power supply, power management board and interface board need to be replaced to address the issue.The interface board had evidence of a thermal event.
 
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Brand Name
TRILOGY 100
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
MDR Report Key7227575
Report Number2518422-2018-00234
Device Sequence Number16173666
Product Code CBK
UDI-Device Identifier00606959023178
UDI-Public00606959023178
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
Report Date (Section B) 01/17/2018
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 Number1054260
Device Catalogue Number1054260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/17/2018
Initial Report FDA Received Date01/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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