Cardiac Science is in Ongoing Discussions with FDA
BOTHELL, WA -- Medical devices maker Cardiac Science Corp. (CSCX: News ) recently received a warning letter from the United States Food and Drug Administration, which notes inadequacies in the voluntary field corrective action announced by the company on November 13, 2009 relating to a component issue, the company said in a filing with the Securities and Exchange Commission Wednesday.
After having inspected the company in the third quarter of 2009, the agency says the company is not in compliance with various Current Good Manufacturing Practice, or CGMP, requirements under applicable FDA regulations.
The company had said in November that it was initiating a voluntary field correction after determining that certain automated external defibrillators or AEDs may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death, it had said.
At that time, the company had received 64 complaints concerning four resistors within certain AEDs. This issue potentially affected around 300,000 Powerheart and CardioVive AED products.
The field corrective action consists of a software update that the company plans to begin making available to customers of the affected devices in February 2010. According to the FDA, this corrective action is inadequate as it is intended to improve the products' ability to detect the potential component problem, and is not designed to prevent component failure.
The letter also asserts other inadequacies, which include the company's procedures relating to the evaluation, investigation and follow up of complaints, procedures to verify the effectiveness of corrective and preventative actions and procedures relating to certain design requirements.
Cardiac Science needs to provide a prompt written response to the warning letter.
The company said it is investigating the issues and observations identified in the letter and are in ongoing discussions with the FDA.
In a separate incident, the company said on February 3 that it was initiating a worldwide voluntary recall after determining that about 12,200 AEDs may not be able to deliver therapy during a resuscitation attempt. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions, the company added.
Cardiac Science said in the latest regulatory filing that in connection with the February 3 recall, the company experienced an interruption in the shipment of certain of its AED products during the first quarter of 2010, though shipments have now resumed.