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

Model Number 1054655

Device Problems Contamination (1120); Degraded (1153); Failure to Recalibrate (1517); Insufficient Information (3190)

Patient Problems Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  malfunction  

Event Description

The manufacturer received information alleging a patient's blood oxygen saturation decreased and the patient was taken to the emergency room for evaluation.The patient was not admitted to the hospital.The device has not yet been returned to the manufacturer.At this time, we are unable to confirm if any malfunction occured.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported a patients blood oxygen saturation decreased and was taken to the hospital.The device was alarming for "service required" alarm conditions.During the evaluation of the device at the manufacturer's service center, the device failed test steps during testing.The overhead blower filter was found to be contaminated, causing the active exhalation control module to fail.The overhead blower filter and active exhalation control module were replaced to address the issues.

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 patients blood oxygen saturation decreased and was taken to the hospital.The device was alarming for "service required" alarm conditions.During the evaluation of the device at the manufacturer's service center, the device failed test steps during testing.The overhead blower filter was found to be contaminated, causing the active exhalation control module to fail.The overhead blower filter and active exhalation control module were replaced to address the issues.During the evaluation, the blower, stirring fan foam and inlet air path assembly 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 rd; 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: 10895646
• MDR Text Key: 217992789
• Report Number: 2518422-2020-02823
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959025387
• UDI-Public: 00606959025387
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1054655
• Device Catalogue Number: 1054655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/09/2020; 11/16/2020
• Supplement Dates FDA Received: 12/10/2020; 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male