The Therapeutic Goods Administration (TGA), Australia issued a medical device safety alert concerning Expression Information Portal - IP5, manufactured by Philips. The affected product number is 865471 and the affected serial numbers are US23200375, US23200376, US23200377.
If the affected product is in use or powered on for an extended period of time (exceeding 24 hours), it may lost all audio function. "All audio" includes touch screen and QRS/SpO2 modulation tones and audible alarms. All other functionality of the affected product is unaffected (waveforms, numeric values, visual alarm indications).
The manufacturer will contact the affected customer to arrange for a software update to correct the problem. End users are requested to power cycle the affected product once every 24 hours and to be aware not to rely solely on audible alarms for alerting of potentially critical patient events.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to TGA website:
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 October 2013