MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100 VENTILATOR, U.S.A - BT; CONTINUOUS, VENTILATOR, HOME USE

Model Number 00

Device Problem No Audible Alarm (1019)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Respiratory Arrest (4461)

Event Date 11/20/2020

Event Type  Death  

Event Description

The patient experienced some type of a respiratory/cardiac arrest event while in bed.The trilogy 100 ventilator did not audibly alarm, which may have influenced the outcome of death.When the log on the ventilator was reviewed, it was confirmed that the ventilator did not generate audible alarm.

• Brand Name: TRILOGY 100 VENTILATOR, U.S.A - BT
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge ln; murrysville PA 15668
• MDR Report Key: 10934167
• MDR Text Key: 219137611
• Report Number: 10934167
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/01/2020,11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00
• Device Catalogue Number: 1054260B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2020
• Device Age: 44 MO
• Event Location: Other
• Date Report to Manufacturer: 12/02/2020
• 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: 1095 DA
• Patient Weight: 12