Cardiac Science alerts users to faulty defibrillator software
Cardiac Science initiated a global voluntary field corrective action on Monday for certain automated external defibrillators (AEDs) manufactured between August 2006 and March 2007.
The company said that some AEDs manufactured in this time frame may have a component whose performance does not match the factory software settings. Under a particular set of conditions, the software places the AED into a ’service required’ mode.
To fix the software and complete the corrective action, the Bothell, Wash.-based Cardiac Science is providing a user-installable software update to customers and distributors using the defibrillators in question.
Cardiac Science said it has begun notifying distributors and customers with affected devices and is shipping software updates to each. The instructions and additional information regarding the affected units are also available at http://www.cardiacscience.com/AEDUpdate.
The company said that it has received two complaints of such a software occurrence while attempting to provide defibrillation. Until the updates arrive, customers are advised to keep their AEDs in service.
The company said it expects to take a pre-tax charge of between $800,000 and $1 million in the third quarter of this year relating to the estimated costs associated with this voluntary action.
Cardiac Science said the action will not affect its AED manufacturing, shipping schedules, or service support to current or new customers.
The company said that some AEDs manufactured in this time frame may have a component whose performance does not match the factory software settings. Under a particular set of conditions, the software places the AED into a ’service required’ mode.
To fix the software and complete the corrective action, the Bothell, Wash.-based Cardiac Science is providing a user-installable software update to customers and distributors using the defibrillators in question.
Cardiac Science said it has begun notifying distributors and customers with affected devices and is shipping software updates to each. The instructions and additional information regarding the affected units are also available at http://www.cardiacscience.com/AEDUpdate.
The company said that it has received two complaints of such a software occurrence while attempting to provide defibrillation. Until the updates arrive, customers are advised to keep their AEDs in service.
The company said it expects to take a pre-tax charge of between $800,000 and $1 million in the third quarter of this year relating to the estimated costs associated with this voluntary action.
Cardiac Science said the action will not affect its AED manufacturing, shipping schedules, or service support to current or new customers.