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

Model Number 1054260

Device Problems Tidal Volume Fluctuations (1634); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Overinflation of Lung (2397); Collapse (2416)

Event Date 01/04/2016

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient was sent to the hospital complaining of shortness of breath and chest pain.The patient was diagnosed as having a collapsed lung and a chest tube was inserted.The device allegedly delivered an increase in tidal volume to the patient.The patient is reportedly fine.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 a ventilator allegedly delivered an increased tidal volume to the patient.The patient became short of breath and was found to have a collapsed lung.A chest tube had to be inserted to treat the collapsed lung.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

It was initially reported that a patient had a collapsed lung while using a ventilator.A follow up report was filed stating that after several unsuccessful requests for the manufacturer, the device would not be returned for investigation.The ventilator was returned to the manufacturer for evaluation and the customer's complaint could not be confirmed or duplicated.The device passed all testing and was found to operate 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
• 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: 5431080
• MDR Text Key: 38042318
• Report Number: 2518422-2016-00549
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959015364
• UDI-Public: 606959015364
• 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: health professional,user faci
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• 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: 02/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention