HeartSafe America; FDA; Medtronic; Physio Control; AED, AEDs

On February 19, 2010, the FDA has released Medtronic/Physio-Control from any and all shipping and manufacturing restrictions. Physio-Control is free to ship worldwide once again.

On February 19, 2010, Medtronic/Physio-Control received approval from the US Food and Drug Administration to resume unrestricted shipments. This approval comes a little over three years after Physio-Control voluntarily suspended shipments as a result of quality system issues identified in a 2006 FDA Audit. Since Physio-Control’s “Stop Ship” announcement in January 2007, they have been working diligently to identify deficiencies and improve all processes. Therefore, in December 2009, Physio-Control completed all of the stipulations set out in 2008 Consent Decree and extended an audit invitation to FDA. After several months of reviewing and re-reviewing all processes, the FDA confirmed Physio-Control to be in compliance and rendered a decision to lift all restrictions.

CLICK HERE to view the letter by Brian Webster, President of Physio-Control.

Contact HeartSafe America today to order all of your Medtronic/Physio-Control products.

Philips Issues Worldwide Recall of Select HeartStart FR2+ AEDs

On September 28, 2009, Philips announced a worldwide recall on the HeartStart FR2+ AEDS. The recall is a voluntary recall, it was not mandated by the FDA. Philips is recalling the HeartStart FR2+ AEDs that were manufactured during May, 2007 thru Janurary, 2008.

The reason for the recall is due to a faulty memory chip in the Philips HeartStart FR2+ AED. Philips is concerned that the memory chip may fail and cause the AED not to function properly.

If you are concerned that your Philips HeartStart FR2+ AED may be part of the recall, you can click on the link below and check your serial number. If you have any questions in regards to the recall or your HeartStart AED, you can contact Philips at 1-800-263-3342.

www.philips.com/FR2PlusAction

If you are interested in the full story that this blog was based on, please click here.

BOMA Associations HeartSafe America, Inc. Dallas TX

HeartSafe America, Inc. Press Release

HeartSafe America and HeartSine Technologies announced the donation of thirteen HeartSine Samaritan(R) PAD automated external defibrillators (AED) to local associations of the BOMA Southwest Region. These associations cover Texas, New Mexico, Louisiana, Arkansas and Oklahoma.

DALLAS, May 28 /PRNewswire/ -- At the Building Owners and Managers Association (BOMA) Southwest Conference meeting in Houston, Texas, HeartSafe America and HeartSine Technologies announced the donation of thirteen HeartSine Samaritan(R) PAD automated external defibrillators (AED) to local associations of the BOMA Southwest Region. These associations cover Texas, New Mexico, Louisiana, Arkansas and Oklahoma.

Because one American dies approximately every two minutes from sudden cardiac arrest (SCA) and because SCA is a leading cause of death in the U.S., claiming an estimated 325,000 lives each year, HeartSafe America and HeartSine are hoping to spread awareness of the need for additional CPR training and the need for AED in the workplace. As many as 30 to 50 percent of SCA victims would likely survive if CPR and AED were used within five minutes of collapse. Used together, these tools can mean the difference between life and death.

The HeartSine Samaritan PAD automatic external defibrillator is ideal for BOMA member businesses and offers the following key benefits:

• Ease of use - designed for the minimally trained user, and suitable for rescuers of all skill levels, voice and visual prompts guide each step of the rescue.
• Low cost of ownership - the patented Pad-Pak contains both batteries and electrodes in one cost-effective, easy-to-replace cartridge, with only one expiration date to monitor.
• Durable and portable - designed to be used in most any environmental condition.

In addition to the donation program, HeartSafe America is also offering a generous discount to all BOMA members in the Southwest Region, and to tenants of member facilities.

Each of the following BOMA associations was offered the free AED donation: Austin, San Antonio, Dallas, Fort Worth, Little Rock, and North Little Rock.

SOURCE HeartSafe America, Inc.Copyright©2009 PR Newswire. All rights reserved.