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

Model Number	DE2110X13B
Medical Device Problem Codes	Contamination (1120); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : not returned to manufacturer.
Event or Problem Description
The manufacturer received information alleging a ventilator had failed to operate.There was no harm or injury reported.The device has not been returned to the manufacturer.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.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging a ventilator had failed to operate.There was no harm or injury reported.The ventilator was evaluated by a third-party service center and the customer¿s complaint was confirmed.The device's machine flow sensor needs to be replaced to address the issue.The machine flow sensor was evaluated by the manufacturer's product investigation laboratory (pil) and found the machine flow sensor was replaced due to contamination.H3 other text : third-party service center.
Additional Manufacturer Narrative
On previously submitted report, section add.Narrative/corrected data was incorrect.It should be ¿the manufacturer previously reported receiving information alleging a ventilator had failed to operate.There was no harm or injury reported.The device was evaluated by the manufacturer's product investigation laboratory (pil) and the customer complaint was confirmed.The device¿s machine flow sensor was replaced due to contamination.

• Brand Name: TRILOGY EVO
• Common Device Name: 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: 17343732
• Report Number: 2518422-2023-16053
• Device Sequence Number: 17866002
• Product Code: CBK
• UDI-Device Identifier: 00606959054110
• UDI-Public: 00606959054110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: DE2110X13B
• Device Catalogue Number: DE2110X13B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 03/05/2024; 04/17/2024
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 04/16/2024; 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown