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

Model Number	1119867
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to a third party service center for evaluation.The device was not in patient use.During the evaluation of the ventilator at the third party service center, a failure of the device to charge it's internal battery was observed.The device's internal battery was replaced to address the issue.

• Brand Name: TRILOGY EC
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• MDR Report Key: 7905473
• Report Number: 2518422-2018-02232
• Device Sequence Number: 1787491
• Product Code: CBK
• UDI-Device Identifier: 00606959022058
• UDI-Public: 00606959022058
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 1119867
• Device Catalogue Number: 1119867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1