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

Model Number 1054096

Device Problems Computer Software Problem (1112); Insufficient Information (3190)

Patient Problem Respiratory Distress (2045)

Event Date 10/24/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator alarmed and shut down for a ventilator inoperative condition.The patient was taken to a hospital er.The manufacturer is currently investigating this event and a follow-up report will be filed when the investigation is complete.

Manufacturer Narrative

It was initially reported, the manufacturer received information alleging a ventilator alarmed and shut down for a ventilator inoperative condition.The patient was taken to a hospital er.The ventilator was returned to the manufacturer for investigation.The device passed all relevant testing and was found to operate and alarm as designed.The ventilator's downloaded event logs were reviewed.Errors related to ventilator inoperative conditions were observed in the event logs.Although the ventilator inoperative conditions could not be duplicated, the manufacturer has determined the ventilator inoperative conditions are software/sd card related.A failed sd card caused the device to go into a ventilator inoperative state, triggering an alarm to alert the user.An error initiated on the sd card causing a device reboot.If there are three reboots within 24 hours, a ventilator inoperative condition will occur to prevent incorrect therapy delivery.

• 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 15668
• MDR Report Key: 9295780
• MDR Text Key: 165583842
• Report Number: 2518422-2019-02553
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

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: 1054096
• Device Catalogue Number: 1054096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• 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): Other