MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1040000
Medical Device Problem Codes	Circuit Failure (1089); 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, a "service required" code was found in the ventilator's downloaded error log.The device's sensor board cable was found to be disconnected.The cable was reconnected to address the issue.
Additional Manufacturer Narrative
The manufacturer previously reported the sensor board cable was reconnected to address a "service required" alarm condition.During further evaluation of the device at the manufacturer's service center, the sensor board was also replaced to address the issue.

• 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 Key: 10802321
• Report Number: 2518422-2020-02660
• Device Sequence Number: 2954142
• Product Code: CBK
• UDI-Device Identifier: 00606959022065
• UDI-Public: 00606959022065
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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 Number: 1040000
• Device Catalogue Number: 1040000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1