Medical device supplier, Philips Healthcare, has issued a medical device safety alert regarding Philips IntelliVue Information Center and Philips IntelliVue Information Center iX. This issue affected all PIIC and PIIC iX products using Hewlett Packard rp5800 PCs.
Philips has identified that an internal audio cable connector may have diminished retention force due to damaged contacts. This diminished retention force could lead to intermittent or loss of audible alarms. Failure to annunciate audio alarms may delay recognition of an alarm condition, if users 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., a bedside monitor. This may result in delayed treatment of the patient.
The manufacturer advises users to observe system for any of the described symptoms. If experiencing intermittent audio or there is no audio from the PIIC / PIIC iX, while it is not connected to another audible alarm annunciation system, users should not rely exclusively on the audible alarm system for patient monitoring. As this issue does not affect video functionality, visual alarming remains operational and close observation of the PIIC / PIIC iX display should be provided.
Philips will replace the audio cable on affected devices.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 December 2012