At the repair bench it was found that there was no audio from the speaker.There was no patient involvement.There was no patient harm reported by the customer.It is unclear whether the device was being used on or off the network at the customer site.If the device is being used off network, in local monitor mode with no central station monitoring, and staff are not observing the device display, in the presence of life-threatening events when no sound is audible, serious injury and/or death can occur.
|