The manufacturer received information alleging a battery depleted alarm while the batteries were fully charged.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation.The manufacturer lab reviewed the event log from the trilogy evo, australia device and noted e-44 and e-54 in the log.The lab then removed ac power and ran therapy on battery power until both the internal and detachable batteries were completely depleted to 0 capacity and then reapplied ac power and charged both batteries to 100% capacity without issue.After further review of the event log it was noted that this is an occurrence of trilogy evo defect# 484.The lab then reinstalled the batteries in the device, placed a red cap on the outlet port of the device and started therapy in cpap mode at 25 cmh2o and after 10:55 minutes simulated a breath and the device started alarming for batteries completely depleted while the batteries were fully charged.The device then corrected itself and then would show the correct charge level of the batteries on the display.The lab concluded that this is an occurrence of defect #484 and is a software issue with the device.
|