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

Model Number 1040004

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/28/2020

Event Type  Death  

Event Description

The manufacturer received information alleging a patient expired while using a ventilator.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 patient expired while using a ventilator.While the ventilator was in use, a low oxygen flow alarm began sounding.The patient was taken off the device and was manually ventilated.The patient later expired.The cause of death was reported as ovarian cancer.During the evaluation of the device at the manufacturer's service center, an issue related to the oxygen blending manifold was observed.The device's oxygen blending manifold was replaced to address the issue.

• Brand Name: TRILOGY O2
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge lane; murrysville, pa PA 15668
• Manufacturer (Section G): RESPIRONICS INC.; 1001 murry ridge lane; murrysville, pa PA 15668
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, pa, PA 15668
• MDR Report Key: 9660406
• MDR Text Key: 177425988
• Report Number: 2518422-2020-00290
• 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,Followup
• Report Date: 02/28/2020

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: 1040004
• Device Catalogue Number: 1040004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2011
• 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
• Patient Age: 67 YR
• Patient Weight: 64