Philips—IntelliVue Information Center iX Systems: SpO2 and Noninvasive Blood Pressure Alarms May Become Disabled
December 24, 2014 | Risk Management News
ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at firstname.lastname@example.org.
In a December 11, 2014, Urgent Field Safety Notice letter submitted by an ECRI Institute member hospital, Philips states that if the configuration for the "Change Bed Label" feature is set to "optional" and a user selects the "Location" button within the "Manage Patient" menu on the systems below and makes a change to the patient location, alarms for Sp02 and/or noninvasive blood pressure (NiBP) may become disabled without visual notification (bell with an "X") to the user, as shown in the letter. Philips states that this problem only happens when the patient is monitored using a networked IntelliVue TRx Telemetry M4841/TRx4851A patient-worn device (PWD). If alarms are disabled without the anticipated visual notification, a patient may experience a change in condition that may not immediately be detected by staff, such as a drop in oxygenation (hypoxia). The manufacturer has not confirmed the...