MAUDE Adverse Event Report: RESPIRONICS INC. TRILOGY O2; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1040004

Device Problem Use of Device Problem (1670)

Patient Problem Respiratory Distress (2045)

Event Date 09/26/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient became disconnected from a ventilator and required resuscitation.The patient returned to baseline.According to the reporter of the event, the ventilator alarmed when the disconnect occurred but the caregiver did not respond in a timely manner.There is no allegation of device malfunction.

• Brand Name: TRILOGY O2
• 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: 9146078
• MDR Text Key: 160932085
• Report Number: 2518422-2019-02227
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093905
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1040004
• Device Catalogue Number: 1040004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• 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