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

Model Number 1054260

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Respiratory Distress (2045)

Event Date 10/01/2019

Event Type  Injury  

Event Description

The manufacturer received information that a patient was hospitalized due to respiratory distress while using the ventilator.The device has not yet been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported a patient was hospitalized while the ventilator was in use.The device was returned to the manufacturer for evaluation.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 manufacturer concludes the ventilator operated and alarmed as designed and did not cause or contribute to the reported event.

• 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 rd; murrysville PA 15668
• Manufacturer Contact: adam price ; 312 alvin dr; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 9224627
• MDR Text Key: 163384657
• Report Number: 2518422-2019-02343
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 27 YR