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

Model Number 1054260

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 09/20/2020

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient developed a pneumothorax while using a ventilator on (b)(6) 2020 and on (b)(6) 2020.The patient subsequently required hospitalization and a chest tube for the events.The device has yet to be returned to the manufacturer for evaluation.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 receiving information alleging a patient developed a pneumothorax on two separate occasions while using a ventilator.The patient required hospitalization and a chest tube as a result of the events.The device was returned to the manufacturer's product quality investigation laboratory for evaluation and was found to operate and alarm as designed.The manufacturer concludes the ventilator did not cause or contribute to the reported event.

• Brand Name: TRILOGY 100
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11358231
• MDR Text Key: 232820109
• Report Number: 2518422-2021-00505
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959026353
• UDI-Public: 00606959026353
• Combination Product (y/n): N
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/24/2021
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR