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

Model Number IN2100X15B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Arrest (4461)

Event Date 11/21/2020

Event Type  Death  

Event Description

The manufacturer received information alleging a patient became disconnected from a ventilator and expired.The ventilator's downloaded event logs were reviewed by the manufacturer.The device maintains the event logs in non-volatile memory.An event, as logged by the device, includes every keypress, alarm or failure of the device to remain within specifications.There were no events logged related to device performance or device malfunctions.If a device malfunction occurred, the event logs would have contained entries related to the malfunction.The reported date of the event is (b)(6) 2020.The event log shows that the ventilator was turned on at 17:45:03 on (b)(6) 2020 and was alarming periodically for the next six (6) hours for low inspiratory pressure.Each time the low inspiratory pressure alarm occurred during this six (6) hours, the alarm self-corrected indicating that the patient condition no longer violated the setting.The alarm was reset at 23:17 with a manual keypress and fio2 was adjusted from 75% to 70%.At 0:32:04 on (b)(6) 2020, there was another low inspiratory pressure alarm sustained for 796 seconds (about 13 minutes).The event log entry indicates that the alarm self-corrected and then shows the ventilator was turned off at 01:01:23 on (b)(6) 2020.The manufacturer concludes the ventilator operated and alarmed as designed.

• Brand Name: TRILOGY EVO
• 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: 10922721
• MDR Text Key: 218801858
• Report Number: 2518422-2020-02867
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181166
• 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
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IN2100X15B
• Device Catalogue Number: IN2100X15B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• 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): Death