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

Model Number 1054096

Device Problem Unexpected Shutdown (4019)

Patient Problem Respiratory Distress (2045)

Event Date 04/23/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator powered off during use.The patient required resuscitation.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 ventilator powered off during use.The patient needed to be resuscitated.The ventilator was returned to the manufacturer's service center for evaluation.The device passed all testing and was found to operate and alarm as designed.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.No deficiencies or issues that would impact therapy were observed.Based on device testing and evaluation of the ventilator's downloaded event logs, the manufacturer concludes the device operated and alarmed as designed during the relevant timeframe.The ventilator 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: 8640152
• MDR Text Key: 146059761
• Report Number: 2518422-2019-01193
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959022744
• UDI-Public: 00606959022744
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1054096
• Device Catalogue Number: 1054096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2014
• 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