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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 02; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC TRILOGY 02; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1040004
Medical Device Problem Codes Circuit Failure (1089); Contamination (1120); Failure to Recalibrate (1517)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/21/2018
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator was alarming related to a low oxygen flow condition.There was no harm or injury reported.The ventilator was returned to the manufacturer's service center for evaluation and the customer's complaint was confirmed.During evaluation, a "service required" code was found in the ventilator's downloaded error log and the device failed a test step due to contaminated from a foreign substance.The device's oxygen blending module board and oxygen blending module flow element were replaced to address the issues.
 
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Brand Name
TRILOGY 02
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
MDR Report Key7693694
Report Number2518422-2018-01648
Device Sequence Number11080002
Product Code CBK
UDI-Device Identifier00606959033887
UDI-Public00606959033887
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K093905
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/21/2018
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 Number1040004
Device Catalogue Number1040004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/21/2018
Initial Report FDA Received Date07/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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