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

Model Number DS2110X11B

Device Problem Battery Problem (2885)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator inoperative condition and internal battery not detected occurred.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

H3 other text : device not returned to manufacturer.

Manufacturer Narrative

Previously reported: the manufacturer received information alleging a ventilator inoperative condition and internal battery not detected occurred.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the device did not shows error coded matching the customers complaint.The errors found during testing were motor calibration, the blower and capacitor were found disconnected.The device was repaired and cleaned to resolve.

• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18832518
• MDR Text Key: 336960154
• Report Number: 2518422-2024-11395
• Device Sequence Number: 1
• Product Code: CBK
• 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: Company Representative
• 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: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DS2110X11B
• Device Catalogue Number: DS2110X11B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1