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

Model Number	IA2100X15B
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to a third party service center for evaluation.There was no harm or injury reported.During the evaluation of the ventilator at the third party service center, the ventilator's tidal volume delivery was low.The device's external flow sensor was replaced to address the issue.

• Brand Name: TRILOGY EVO
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• MDR Report Key: 11563264
• Report Number: 2518422-2021-00860
• Device Sequence Number: 19572175
• Product Code: CBK
• UDI-Device Identifier: 00606959055636
• UDI-Public: 00606959055636
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: Health Professional
• Device Model Number: IA2100X15B
• Device Catalogue Number: IA2100X15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1