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

Model Number 1040004

Device Problems Circuit Failure (1089); Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/30/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient's blood oxygen saturation decreased while on a ventilator.The patient was switched to another ventilator.The device has been returned to the manufacturer but the investigation is still ongoing.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported receiving information alleging a patient's blood oxygen saturation decreased while on a ventilator.The patient was switched to another ventilator.The evaluation was completed at the manufacturer's service center and the customer's complaint was confirmed, a "service required" code was observed in the ventilator's downloaded event log.The device's oxygen blending module board 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 15668
• MDR Report Key: 11665005
• MDR Text Key: 245372708
• Report Number: 2518422-2021-01072
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959025394
• UDI-Public: 00606959025394
• Combination Product (y/n): N
• PMA/PMN Number: K093905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/18/2021

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?: Yes
• 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: 03/30/2021
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention