Philips IntelliVue Patient Monitors

Issue

Philips IntelliVue patient monitors provide a feature for pausing all alarms for a configured timeframe or for switching all alarms off for an infinite period until they are switched back on by the user. The infinite alarms off feature is an important functionality in specific clinical environments such as the operating room, cath lab or during resuscitations to reduce the audible alarms which may present unnecessary distractions during closely monitored procedures or interventions. Philips has received complaints that the IntelliVue monitors did not alarm. In some cases, these complaints alleged delayed patient treatment due to the monitors not alarming; and, in some cases, there were reports of severe patient harm or death. It was determined that in these instances the alarms had been switched off for an infinite period, and the user may have been unaware that the alarms were off.