On Nov. 10, the U.S. Food and Drug Administration posted a voluntary recall notice for all Automated External Defibrillators manufactured by Access CardioSystems Inc.

Additionally, Access CardioSystems has gone out of business and will no longer be providing service, repair or technical support for any AEDs currently in the field, nor is it selling consumable products, such as battery packs and electrode sets, for those AEDs. Details of the recall are below.

Because Access CardioSystems is no longer providing support or disposable parts for its products, the company recommends that those AEDs not covered under the recall should be pulled from service when the department runs out of supplies. The company's web site, http://www.accesscardiosystems.com/,has posted contact inforamtion for their recall coordinator. For more information,contact (978) 405-1057 or e-mail recall@accesscardiosystems.com.

The EMS Section of the International Association of Fire Chiefs has been in contact with AED manufacturers in order to facilitate reasonable solutions for fire departments that currently use Access CardioSystems AEDs. We encourage members to contact defibrillator manufacturers to discuss opportunities for discount pricing when replacing Access CardioSystems Defibrillators. An example of such a program is at the bottom of this article.

Recall Details (as outlined in the Access CardioSystems recall announcement)

Defibrillators that have the serial numbers listed below should immediately be pulled from service.

AccessAED, AccessALSCatalog Number: 9100-0100
Affected Serial Numbers: 075690 – 077140
Defect: Failure to Deliver Shock

AccessAED, AccessALS
Catalog Number: 9100-0100
Affected Serial Numbers: 075180 – 084760
Defect: Turn on Unexpectedly

The company has identified two problems with the AEDs listed above. The defibrillators with serial numbers 075690 – 077140 may experience a catastrophic failure of the shock delivery circuit. To date, the company has received 11 complaints of this occurrence in devices containing the component shown to be associated with this failure mode (representing a 0.8% complaint rate within the affected units). When this potential problem occurs, it is not possible to deliver additional defibrillation shocks.

The second problem, for AEDs with serial numbers 075180 – 084760, involves the “ON/OFF” button. In some cases, the “ON/OFF” button of the device may become inoperative after the device turns on unexpectedly. The company’s investigation indicates to date that this failure mode is related to a specific manufacturer of a specific device component. To date, the company has received 33 complaints of this occurrence in devices containing the component (representing a 0.3% complaint rate within the affected units), none of which have involved a patient treatment. If this potential problem occurs, the device may not defibrillate.

The International Association of Fire Chiefs recommends that fire departments using Access CardioSystems AEDs contact other manufacturers to replace their AEDs. Some manufacturers are offering discounted pricing when the purchaser returns an Access CardioSystems AED with the purchase. The IAFC EMS Section worked with Medtronic to create the program detailed below.

In response to the Access Cardiosystems AED recall and company closure, Medtronic Emergency Response Systems has created a program to assist Access EMS customers during this time of crisis. To meet this immediate public safety need, we are offering LIFEPAK AED solutions in our “Better Access to Defibrillation” offer, including:

• Pricing of $1,000 to purchase a LIFEPAK Express AED (when an AccessAED is sent to Medtronic for proper disposal)
• Pricing of $1,500 to purchase a LIFEPAK 500 AED (when an Access AEDis sent to Medtronic for proper disposal)
• Financing options:
  

To contact Medtronic Emergency Response Systems regarding this program, contact your local sales representative or call 800-442-1142, ext. 5013.