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

Model Number 1054260

Device Problem Use of Device Problem (1670)

Patient Problem Respiratory Distress (2045)

Event Date 05/06/2020

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient required hospitalization while using a ventilator.The ventilator was returned to the manufacturer for evaluation.The device passed all testing and was found to operate and alarm as designed.The ventilator's downloaded event logs were reviewed by the manufacturer.The device maintains the event logs in non-volatile memory.An event, as logged by the device, includes every keypress, alarm or failure of the device to remain within specifications.There were no events logged related to device performance or device malfunctions.If a device malfunction occurred, the event logs would have contained entries related to the malfunction.The reported event occurred on (b)(6) 2020.On the reported date of the event the ventilator alarmed for low exhaled tidal volume, patient disconnect and low minute ventilation at 5:27:24 local time.These alarms sounded for approximately 10 minutes before being acknowledged at 5:57:21 local time as evidenced by an alarm silence/reset keypress.The device was powered off at 5:57:22 local time.Based on test results and review of the downloaded event logs, the manufacturer concludes the ventilator operated and alarmed as designed.The reported event appears to have been caused by a patient circuit disconnect condition.

• Brand Name: TRILOGY 100
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge lane; murrysville, pa
• Manufacturer (Section G): RESPIRONICS INC.; 1001 murry ridge lane; murrysville, pa
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, pa
• MDR Report Key: 10105489
• MDR Text Key: 193069454
• Report Number: 2518422-2020-01334
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2020

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: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 15 YR