The manufacturer received information alleging a patient expired while on a trilogy device.There was no allegation of device malfunction.The device was returned to the manufacturer's product investigation laboratory for investigation.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.If a malfunction occurred, the event logs would have contained entries related to a device malfunction.The manufacturer confirms this device was in use on (b)(6) 2020, the date of the reported event.On the reported date of event, the device was alarming frequently for patient disconnect alarm conditions.The circuit disconnect alarm with the longest duration of approximately 27 minutes was observed on (b)(6) 2020.The device passed all testing and was found to operate and alarm as designed.No deficiencies or issues that would impact therapy were observed.
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