MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1040000
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator was experiencing a board failure.The device was not in patient use.The device has yet to be returned to the manufacturer for evaluation.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 received information alleging a ventilator was experiencing a board failure.The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's sensor board needs to be replaced to address the issue.

• Brand Name: TRILOGY 202
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge drive; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge drive; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; head of quality, src; 6501 living place; pittsburgh, PA 15206 ; 7249003460
• MDR Report Key: 12517940
• Report Number: 2518422-2021-04352
• Device Sequence Number: 1113308
• Product Code: CBK
• UDI-Device Identifier: 00606959022065
• UDI-Public: 00606959022065
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: 1040000
• Device Catalogue Number: 1040000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2018
• 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