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

Model Number 1040000

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2020

Event Type  malfunction  

Event 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 device at a third party service center, "service required" codes were found in the ventilator's downloaded error log.The device's speaker kit was replaced to address the issue.

• Brand Name: TRILOGY 202
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge rd; murrysville, pa
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge rd; murrysville, pa
• Manufacturer Contact: adam price ; 312 alvin dr; new kensington, pa ; 3349303
• MDR Report Key: 10009236
• MDR Text Key: 189319974
• Report Number: 2518422-2020-01099
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1040000
• Device Catalogue Number: 1040000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1