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

Model Number RJP2110X16B

Device Problems Defective Alarm (1014); Noise, Audible (3273)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

A ventilator was returned to the manufacturer for service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, a "service required" code was found in the ventilator's downloaded error log indicating a failure in buzzer as the corresponding alarm.The device's buzzer assembly was replaced to prevent recurrence.Noise coming from fan #2 was confirmed by operational checking cooling fan assembly was replaced.The device passed final testing.

Manufacturer Narrative

It was previously reported that a ventilator was returned to the manufacturer for service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, a "service required" code was found in the ventilator's downloaded error log indicating a failure in buzzer as the corresponding alarm.The device's buzzer assembly was replaced to prevent recurrence.Noise coming from fan #2 was confirmed by operational checking cooling fan assembly was replaced.The device passed final testing.The device buzzer and exhaust fan were return to philips investigation laboratory (pil).During the investigation pil installed the trilogy evo exhaust fan on the trilogy evo stb and then started the fan via rasp.Pil ran the exhaust fan for approximately 20 minutes and then started and stopped the exhaust fan several times and pil did not note any unexpected noise from the fan.Pil concluded that the exhaust fan operates as designed.The trilogy evo exhaust fan has been scrapped.The technician did not confirm a problem with the backup buzzer itself.Therefore, no further investigation of the backup buzzer is required at this time.

• Brand Name: TRILOGY EVO
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18432328
• MDR Text Key: 331813864
• Report Number: 2518422-2024-00180
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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: Lay User/Patient
• Device Model Number: RJP2110X16B
• Device Catalogue Number: RJP2110X16B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1