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

Model Number 1054260

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/11/2020

Event Type  Death  

Event Description

The manufacturer received information alleging a patient expired while using a trilogy device.The patient's tubing became disconnected from their mask and no alarms were noted.The durable medical equipment company states the alarms were turned off due to the patient being placed on hospice care.The device is being returned to a third party service center for evaluation.At this time, we are unable to confirm any malfunction.A follow-up report will be submitted when the third party service center investigation is complete.

Manufacturer Narrative

The manufacturer previously reported a patient expired while using a trilogy device.The patient's tubing became disconnected from their mask and no alarms occurred due to the alarms being turned off by the durable medical equipment company.The device was returned to a third party service center and the device's event log was downloaded.Review of the event log confirms no malfunction of the device occurred.On the date of the patients death, the device was turned on and off repeatedly.No alarms indicating a malfunction were noted.The manufacturer concludes the ventilator operated 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
• MDR Report Key: 10138649
• MDR Text Key: 194651512
• Report Number: 2518422-2020-01391
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• 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?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR