Medical device manufacturer, Philips, has issued a medical device safety alert concerning its M3002A (865039) IntelliVue X2 and M8102A (865040) IntelliVue MP2 manufactured prior to 2011. The affected devices are identified as follows:
According to the manufacturer, speakers on IntelliVue X2 and IntelliVue MP2 may fail. This failure may be identified by the display of a "Speaker Malfunct." INOP or by the absence of audible sound. Speaker failures may delay recognition of an alarm condition, if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system, e.g., another bedside monitor or a central monitoring station. This may result in delayed treatment of the patient.
Affected products may continue to be used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP at power-up.
If affected users experience this INOP or there is no sound from their X2 / MP2 speaker while it is not connected to another audible alarm annunciation system, they should remove the device from use and contact the manufacturer.
The manufacturer will arrange to replace affected speaker assemblies.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 9 December 2020