Caution Urged on Powerheart and CardioVive Automated External Defibrillators - @ JEMS.com


Caution Urged on Powerheart and CardioVive Automated External Defibrillators


 
 

U.S. Fire Administration | | Friday, February 5, 2010


Caution Urged on Powerheart and CardioVive Automated External Defibrillators

The Food and Drug Administration (FDA) is alerting users of certain Powerheart and CardioVive automated external defibrillators that these devices may malfunction unexpectedly. This can cause a failure to deliver the electric shocks that are needed to treat sudden cardiac arrest or arrhythmias.

FDA is alerting users of certain Powerheart and CardioVive automated external defibrillators that these devices may malfunction unexpectedly. This can cause a failure to deliver the electric shocks that are needed to treat sudden cardiac arrest or arrhythmias.



The manufacturer, Cardiac Science Corporation, has received multiple complaints that these devices have malfunctioned, and that their self-test features may not show that there's anything wrong. Before each use, operators are supposed to check for a green light on the front of the AED that shows the device is rescue-ready. But the light may come on even when certain electronic components inside the device have failed.



Malfunctions could cause these AEDs to interrupt ECG analysis and thus prevent shock delivery, or fail to recognize that the pads have been placed. Malfunctions could also cause interference or background noise, which could prevent the device from accurately analyzing heart rhythm and delivering a shock.



About 300,000 Cardiac Science G3 series Powerheart and CardioVive AEDs are affected by this problem worldwide. They were manufactured between August 2003 and August 2009. FDA recommends that users contact Cardiac Science Corporation immediately to arrange for repairs or replacement.



Until the company repairs or replaces the affected devices, FDA recommends that users switch to alternate AEDs if they are available, or that they consider obtaining another AED. If an alternate AED is not available, trained responders should use manual defibrillators. If a manual defibrillator is not available, responders should use the Powerheart or CardioVive AEDs, since they may still be able to deliver the necessary shock.



In the home or in public places, FDA recommends continuing to use these devices if an alternate AED is not available. That's because the consequences of not trying to defibrillate a patient outweigh the risk that the AED may fail.



FDA is gathering more data about this situation, and as we learn more, we will share any new information that might affect the use of these AEDs.

Additional Information:




Connect: Have a thought or feedback about this? Add your comment now
Related Topics: Industry News

What's Your Take? Comment Now ...

Buyer's Guide Featured Companies

Featured Careers & Jobs in EMS

Get JEMS in Your Inbox

 

Fire EMS Blogs


Blogger Browser

Today's Featured Posts

 

EMS Airway Clinic

Innovation & Advancement

This is the seventh year of the EMS 10 Innovators in EMS program, jointly sponsored by Physio-Control and JEMS.
More >

Multimedia Thumb

Salt Lake City Firefighters Injured in Firehouse Fire

Nine sent to a hospital with smoke inhalation.
Watch It >


Multimedia Thumb

Pennsylvania Paramedic Killed in the Line of Duty

West End Ambulance medic killed at accident scene.
Watch It >


Multimedia Thumb

Wesleyan Students Hospitalized for Overdose

11 students transported to local hospitals.
Watch It >


Multimedia Thumb

Rigs Going in Service from EMS Today 2015

Snap shots of some of the vehicles at EMS Today that will be on the streets soon
More >


Multimedia Thumb

Florida Hospital Fire

Fire halts construction project at Tampa cancer center.
More >


Multimedia Thumb

VividTrac offered by Vivid Medical - EMS Today 2013

VividTrac, affordable high performance video intubation device.
Watch It >


Multimedia Thumb

Braun Ambulances' EZ Door Forward

Helps to create a safer ambulance module.
Watch It >


Multimedia Thumb

The AmbuBus®, Bus Stretcher Conversion Kit - EMS Today 2013

AmbuBus®, Bus Stretcher all-hazards preparedness & response tool
Watch It >


Multimedia Thumb

Field Bridge Xpress ePCR on iPad, Android, Kindle Fire

Sneak peek of customizable run forms & more.
Watch It >


More Product Videos >