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

Model Number 1040007

Device Problem Defective Alarm (1014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator low pressure alarm malfunctioned.There was no harm or injury reported.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.

Manufacturer Narrative

The manufacturer previosuly reported an allegation of a ventilator's low pressure alarm was not working.The device was returned to the manufacturer for evaluation and the customer's complaint could not be duplicated.The device was found to operate and alarm as designed.

Manufacturer Narrative

Sections d8, d9 and g4 (combination product ) corrected in this report.

Manufacturer Narrative

Section h10 was incorrectly reported in the follow up-1 report.It has to be the manufacturer previosuly reported an allegation of a ventilator's low pressure alarm was not working.The device was returned to manufacturer service center for evaluation.The device powered on and operated as it should.No problems were found.The device's downloaded logs were reviewed by the manufacturer.Since there were so many error code 110s in the log on one single day, replaced the aecm for discretion for possible intermittent problem.The low pressure alarm works as it should.Also found the front enclosure cracked at the handle and 2 boss inserts on one side broken indicating a possible drop.Also found a small crack on the handle.Replaced all listed.The manufacturer concludes that they could not confirm the customer's complaint and no problem found.The device was found to operate and alarm as designed.

• Brand Name: TRILOGY 202
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13965738
• MDR Text Key: 296790590
• Report Number: 2518422-2022-12193
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959005150
• UDI-Public: 00606959005150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2023

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
• Device Operator: Health Professional
• Device Model Number: 1040007
• Device Catalogue Number: 1040007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 04/08/2022; 04/08/2022; 04/08/2022
• Supplement Dates FDA Received: 12/20/2022; 07/12/2023; 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2017
• 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