Cardiac Science recently announced we would be implementing an AED Field Corrective Action. There are two components in our AEDs that can fail in rare occasions and we want to do what we can to improve their reliability. The likelihood a device would fail to deliver therapy as a result of one of these component failures is extremely remote – only 1 in 75,000. Still, we have improved the reliability of our devices we’re currently shipping and want to extend that same reliability enhancement to our existing customers.
We’ve worked closely with FDA throughout the last couple of months. The staff at FDA are responsibly performing their duty to protect public health…we respect and appreciate their efforts. Their current position indicates they still have some open questions and our engineers are working with theirs to review and analyze our data so FDA can better understand the appropriateness of our actions. We look forward to resolving any remaining questions from FDA and bringing this issue to closure.
Cardiac Science has taken a very conservative approach throughout this process. You may recall we stopped shipping for five weeks this summer while we investigated and fixed the issue in production. We also brought in several outside experts to assist us in determining an appropriate set of actions; these experts included cardiologists, emergency medicine physicians, retired FDA professionals, and risk engineers. Additionally, we’ve committed huge resources to implement a software update to further enhance the reliability of our AEDs in the field despite the very low probability a device would ever fail to deliver therapy. All of this has been done despite the fact that our devices are performing within their design specifications and are by all measures extremely reliable.
Our company’s vision includes an imperative to improve public health. We take that responsibility very seriously and look forward to putting this issue behind us so we can bring more life saving therapies to our customers.
Forward-Looking Statements
This story, as well as other elements on this Web site (including the blog), may contain forward-looking statements. The words “believe,” “expect,” “intend,” “anticipate,” variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking.
Forward-looking statements in this story may include, but are not limited to, those relating to the Cardiac Science AED Field Corrective Action, our conversations with FDA, and the resulting impact on operating results.
You can find our full forward-looking statement disclosure on the legal page of this Web site.
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Last 5 posts by Joe Hage
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Fri, Nov 20, 2009 |
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