MAUDE Adverse Event Report: RESPIRONICS INC TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1040007

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

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator failed to alarm when a circuit disconnect occurred and the patient required cardiopulmonary resuscitation in response to the alleged event.The device was returned to the manufacturer's product investigation laboratory for investigation.The ventilator's downloaded event logs were reviewed by the manufacturer and the manufacturer confirmed that the device did alarm appropriately on the date of the alleged incident to alert the caregiver of multiple circuit disconnect conditions.The device was tested and found to operate within specifications and volume requirements.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 manufacturer concludes the ventilator operated and alarmed as designed and did not cause or contribute to the reported event.

• Brand Name: TRILOGY 202
• 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: 10636926
• MDR Text Key: 210089343
• Report Number: 2518422-2020-02285
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959005150
• UDI-Public: 00606959005150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1040007
• Device Catalogue Number: 1040007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2010
• 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): Required Intervention