MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1054260

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator had a thermal event and flames were observed when connecting to a laptop for evaluation.The device was not in patient use.The device has not yet been evaluated by the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported a ventilator had a thermal event and flames were observed when connecting to a laptop for evaluation.The device was returned to the manufacturer's product investigation laboratory for evaluation.The device failed to connect to communicate with the laptop.There was no evidence of thermal damage exterior to the device.There was evidence of a thermal event on the interface board.Damage was observed to the u7 component on the interface board.The interface board will need replaced by the service center to address the issue.

• Brand Name: TRILOGY 100
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13179092
• MDR Text Key: 283333841
• Report Number: 2518422-2022-00437
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2011
• 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