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

Model Number	1134712
Medical Device Problem Codes	Contamination (1120); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a flow sensor stopped working while being used with a trilogy evo.The patient did not have a back up ventilator to use so the patient was admitted to the hospital.There was no report of patient harm or injury.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported a flow sensor allegedly stopped working while being used with a trilogy evo.The patient did not have a back up ventilator to use so the patient was admitted to the hospital.There was no report of patient harm or injury.The flow sensor was returned to the manufacturer's quality product investigation laboratory for further investigation, the customer's complaint was confirmed.The manufacturer found the flow sensor body and electrical contacts to have evidence of contamination causing the flow sensor to not communicate with the device properly.

• Brand Name: TRILOGY EVO
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 10677617
• Report Number: 2518422-2020-02276
• Device Sequence Number: 3209318
• Product Code: CBK
• UDI-Device Identifier: 00606959050846
• UDI-Public: 00606959050846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 1134712
• Device Catalogue Number: 1134712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRILOGY EVO; TRILOGY EVO