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

Model Number 1040007

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Device has been evaluated but not yet repaired pending the customer's approval of the service estimate.

Event 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 failure of the device to power on was observed.The device's system board needs to be replaced to address the issue.

Manufacturer Narrative

The device failed a step during testing.The device's power management board was replaced to address the issue.

• Brand Name: TRILOGY 202
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 7600928
• MDR Text Key: 111034737
• Report Number: 2518422-2018-01402
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959005150
• UDI-Public: 00606959005150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1040007
• Device Catalogue Number: 1040007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1