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

Model Number DS2110X11B

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information alleging a ventilator service required with the error code 384 keypad not functioning.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer received information alleging a ventilator service required with the error code 384 keypad not functioning.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the error code was confirmed.The machine flow sensor was the cause due to contamination.The machine flow sensor was scrapped.The keypad was inspected and did not detect any defects.

• Brand Name: TRILOGY EVO
• 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: jenn canada ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18084718
• MDR Text Key: 327538084
• Report Number: 2518422-2023-29253
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959051942
• UDI-Public: 00606959051942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DS2110X11B
• Device Catalogue Number: DS2110X11B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1