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

Model Number 1054096

Device Problems Degraded (1153); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation conclusion = device has been evaluated but not repaired, pending customer approval of the estimate.

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred.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 blower motor needs replaced to address the issue.During evaluation, an issue related to the active exhalation control module was observed.The device's active exhalation control module needs replaced to address the issue.

Manufacturer Narrative

The manufacturer previously reported a failure of the active exhalation control module was observed during testing.Additional testing indicates the active exhalation control module functioned as designed and will not be replaced as previously indicated.Device has been evaluated but not repaired, pending customer approval of the estimate.

Manufacturer Narrative

This mdr is being submitted as part of a batch submission of previously closed complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.The manufacturer previously reported a failure of the active exhalation control module was observed during testing.Additional testing indicates the active exhalation control module functioned as designed and will not be replaced as previously indicated.Device has been evaluated but not repaired, pending customer approval of the estimate.During the evaluation, the blower, removable air path foam and filter were replaced due to dirt contamination.

• Brand Name: TRILOGY 100
• 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 ; head of quality, src; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 7544685
• MDR Text Key: 109306101
• Report Number: 2518422-2018-01273
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959022744
• UDI-Public: 00606959022744
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

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: 1054096
• Device Catalogue Number: 1054096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 05/28/2018; 05/09/2018
• Supplement Dates FDA Received: 06/05/2018; 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: FDA RES 88071
• Patient Sequence Number: 1