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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY EC; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC TRILOGY EC; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1119867
Medical Device Problem Codes Failure to Charge (1085); Incorrect Or Inadequate Test Results (2456); Device Operational Issue (2914)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/07/2017
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator failed to charge its internal battery.The device was not in patient use.The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's internal battery was replaced to address the issue.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 and the device failed test steps during testing.The device's power management board and sensor board were replaced to address the issues.
 
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Brand Name
TRILOGY EC
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
MDR Report Key6442270
Report Number2518422-2017-00773
Device Sequence Number310333
Product Code CBK
UDI-Device Identifier00606959022058
UDI-Public00606959022058
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K083526
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 03/07/2017
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 Number1119867
Device Catalogue Number1119867
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/07/2017
Initial Report FDA Received Date03/29/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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