MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number R1054655TP

Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198)

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

Event Date 02/16/2024

Event Type  malfunction  

Event Description

The manufacturer received information alleging trilogy 100 screen displayed nothing and remained black.The family member stated airflow was delivered when the unit was turned on and that the issue occurred several times over several days.A sales rep confirmed the reported issue but could not confirm any alarms recorded in the event log.The rep did confirm circuit disconnect at suctioning and low minute ventilation in the event log.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was not duplicated therefore was not confirmed.Since a temporal failure could have occurred in lcd, lcd was replaced preventively to address the issue.

• Brand Name: TRILOGY100
• 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; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18987071
• MDR Text Key: 338717865
• Report Number: 2518422-2024-15372
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Other
• Device Model Number: R1054655TP
• Device Catalogue Number: R1054655TP
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1