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

Model Number	1054655
Medical Device Problem Code	Failure to Recalibrate (1517)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for routine preventative maintenance.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, the device failed a test step during testing.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 rd; murrysville PA 15668
• MDR Report Key: 8063864
• Report Number: 2518422-2018-02629
• Device Sequence Number: 2418448
• Product Code: CBK
• UDI-Device Identifier: 00606959033887
• UDI-Public: 00606959033887
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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: 1054655
• Device Catalogue Number: 1054655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1