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

Model Number 1054655

Device Problem No Flow (2991)

Patient Problem Cognitive Changes (2551)

Event Date 12/12/2017

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient's level of consciousness decreased while he was on a ventilator.The patient recovered.On the reported day of the event, (b)(6) 2017, the ventilator began alarming for circuit disconnect and low inspiratory pressure conditions.The patient was found to be in a state of decreased consciousness and was taken off the device and manually ventilated.When the device was checked, it was observed that a plastic bag had been drawn into the ventilator's air inlet occluding it.The plastic bag was removed and the patient was placed back on the device without incident.The ventilator was placed at the request of the user facility.The ventilator was returned to the manufacturer for evaluation.The device passed all testing and was found to operate and alarm as designed.The manufacturer concludes the event was caused by an obstruction of the ventilator's air inlet.

• Brand Name: TRILOGY 100
• 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: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 7134501
• MDR Text Key: 95369493
• Report Number: 2518422-2017-02936
• Device Sequence Number: 1
• Product Code: CBK
• 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,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• 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): Other
• Patient Age: 34 YR