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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1040007
Medical Device Problem Code Device Operational Issue (2914)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/25/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Device has been evaluated but not repaired.The device was scrapped.
 
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, "service required" codes were found in the ventilator's downloaded error log.The device's power management board, system board and internal battery need replaced to address the issues.
 
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Brand Name
TRILOGY 202
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
MDR Report Key5882707
Report Number2518422-2016-03435
Device Sequence Number1172669
Product Code CBK
UDI-Device Identifier00606959026247
UDI-Public00606959026247
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K093905
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) 07/25/2016
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 Number1040007
Device Catalogue Number1040007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2016
Initial Report FDA Received Date08/17/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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