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

Model Number	1134711
Medical Device Problem Code	Tidal Volume Fluctuations (1634)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a malfunction of a ventilator's external flow sensor causing decreased tidal volumes.There was no harm or injury reported.The component has not yet 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 malfunction of a ventilator's external flow sensor causing decreased tidal volumes.There was no harm or injury reported.The component was returned to the manufacturer's product investigation laboratory and the customer's complaint was not duplicated.The component was found to operate and alarm as designed.

• Brand Name: TRILOGY EVO
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 12141864
• Report Number: 2518422-2021-02113
• Device Sequence Number: 4170381
• Product Code: CBK
• UDI-Device Identifier: 00606959050839
• UDI-Public: 00606959050839
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 1134711
• Device Catalogue Number: 1134711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1