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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1032800
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/02/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device has been repaired but not returned to the customer, pending customer approval of estimate.
 
Event or Problem Description
The manufacturer received information alleging a "service required" alarm condition occurred.There was no harm or injury reported.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 internal battery was replaced to address the issue.
 
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Brand Name
TRILOGY 200
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
MDR Report Key5678432
Report Number2518422-2016-02288
Device Sequence Number18879310
Product Code CBK
UDI-Device Identifier00606959022829
UDI-Public606959022829
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K093416
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 05/02/2016
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 Number1032800
Device Catalogue Number1032800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/02/2016
Initial Report FDA Received Date05/25/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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