MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1054096
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator would not power on.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's system board was replaced to address the issue.

• Brand Name: TRILOGY 100
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 7804508
• Report Number: 2518422-2018-01958
• Device Sequence Number: 1052718
• Product Code: CBK
• UDI-Device Identifier: 00606959022805
• UDI-Public: 00606959022805
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

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: 1054096
• Device Catalogue Number: 1054096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1