Biosense Webster—SMARTABLATE Radio-Frequency Generator Systems: May Inadvertently Deliver Radio-Frequency Energy under Specific Conditions

April 1, 2015 | Risk Management News

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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 clientservices@ecri.org.

In a March 18, 2015, Urgent Field Safety Notification letter submitted by an ECRI Institute member hospital, Biosense Webster states that it has received reports of the generators below delivering RF energy without operator intervention if the footpedal is near and oriented toward the Stereotaxis magnets. Biosense Webster also states that this problem is easily identified by a constant high-pitched tone and the red color of the ablation catheter tip on the CARTO 3 system. The firm further states that if the delivery of RF energy is not stopped immediately by use of the stop button on the generator and/or the generator remote control, there is a risk to patients when the catheter is in use; however, Biosense Webster has received no reports of patient harm associated with this problem. The manufacturer has not confirmed the...

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