Important Safety Alerts

Important Safety Alerts

Field Safety Notice: Philips IntelliVue patient monitors

14 Feb 2012

The Medicines and Healthcare products Regulatory Agencies (MHRA), United Kingdom posted a field safety notice concerning Philips IntelliVue patient monitors.

Philips has recently received reports that, under certain circumstances, alarms announced at the patient monitor are not announced (either visual or audible) at the central station. Only the below referenced models with SW Revision H (up to and including H.15.36) are affected.
MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), Intelligent Display D80 (M8016A), MX600 (865242), MX700 (865241) and MX800 (865240)

If a patient develops a condition leading to an alarm and is being monitored with a monitor which has entered the state where alarm information is not communicated to the central station, clinical personnel monitoring the central station may not be advised of an alarm condition. This could cause a delayed response to the alarm condition of the patient.

Philips will conduct software upgrade to the affected devices.

For details, please refer to the following MHRA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm

If you are in possession of the affected product, please contact your supplier for necessary actions.

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