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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 Battery Problem (2885)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/20/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device has been evaluated but not yet repaired.
 
Event or Problem Description
The manufacturer received information alleging a failure of a ventilator's internal battery.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, an error code related to the charging of the internal battery was observed.The device's internal battery needs to be 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 lane
murrysville PA 15668
MDR Report Key7337396
Report Number2518422-2018-00605
Device Sequence Number11255570
Product Code CBK
UDI-Device Identifier00606959026322
UDI-Public00606959026322
Combination Product (Y/N)N
Initial Reporter StateCO
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) 02/20/2018
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 Medical Equipment Company Technician/Representative
Device Model Number1054260
Device Catalogue Number1054260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/20/2018
Initial Report FDA Received Date03/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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