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

Model Number 1054260

Device Problems Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 07/15/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text: device not returned to manufacturer.

Event Description

The manufacturer received information alleging a ventilator was involved with a house fire.Information was received that the patient had life-threatening burns.The patient was taken to a trauma center.Details of medical intervention were not provided.The device has not been returned to the manufacturer.At this time, we are unable to confirm any alleged malfunction.A report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported information alleging a ventilator was involved with a house fire.Information was received that the patient had life-threatening burns.The patient was taken to a trauma center.Details of medical intervention were not provided.Request for the device information was received.Information has been updated on the report and are as follows.Sn (b)(6), material 1054260, and udi (b)(4).

Manufacturer Narrative

The manufacturer previously reported information alleging a ventilator was involved with a house fire.Information was received that the patient had life-threatening burns.The patient was taken to a trauma center.Details of medical intervention were not provided.The device has not been returned to the manufacturer.At this time, we are unable to confirm any alleged malfunction.A report will be submitted when the manufacturer's investigation is complete.Two serial numbers were originally listed for device information which was not included in original report.Only one device was involved in event.The serial numbers provided were sn: (b)(6) and sn: (b)(6).A request has been sent for clarification of which device was involved.

• Brand Name: TRILOGY 100
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17637006
• MDR Text Key: 322109917
• Report Number: 2518422-2023-20483
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 5 YR
• Patient Sex: Male