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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 1119867
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/22/2018
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer received information alleging a "service required" alarm condition occurred.The device was not in patient use.The ventilator was returned to the manufacturer for evaluation and an error code related to the charging of the internal battery was observed.The device's internal battery 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 rd
murrysville PA 15668
MDR Report Key7247400
Report Number2518422-2018-00275
Device Sequence Number13707615
Product Code CBK
UDI-Device Identifier00606959022058
UDI-Public00606959022058
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) 01/22/2018
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 Number1119867
Device Catalogue Number1119867
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/22/2018
Initial Report FDA Received Date02/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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