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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 1040000
Medical Device Problem Code Obstruction of Flow (2423)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/19/2020
Type of Reportable Event Malfunction
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, the ventilator was alarming for a "service required" alarm condition.The device's oxygen blending module board cable was found to be disconnected.The cable was reconnected to address the issue.
 
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Brand Name
TRILOGY 202
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
MDR Report Key10802316
Report Number2518422-2020-02655
Device Sequence Number14191524
Product Code CBK
UDI-Device Identifier00606959022065
UDI-Public00606959022065
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K093905
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/05/2020
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 Number1040000
Device Catalogue Number1040000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/19/2020
Initial Report FDA Received Date11/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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