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

Model Number	1054096
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator was shutting down.There was no harm or injury reported.The device has not yet been returned for evaluation by 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.
Additional Manufacturer Narrative
It was initially reported, the manufacturer received information alleging a ventilator was shutting down.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation.The ventilator 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 manufacturer concludes the device operates and alarms as designed.The customer's complaint could not be comfirmed or duplicated.

• Brand Name: TRILOGY 100
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11124441
• Report Number: 2518422-2021-00038
• Device Sequence Number: 631693
• Product Code: CBK
• UDI-Device Identifier: 00606959022805
• UDI-Public: 00606959022805
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1054096
• Device Catalogue Number: 1054096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1