FDA Posted A Recall Notice For All AEDs. 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 information for their recall coordinator.
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.
Recalled AEDs Serial Numbers
AccessAED, AccessALSCatalog Number: 9100-0100
Affected Serial Numbers: 075690 â€“ 077140
Defect: Failure to Deliver Shock
Catalog Number: 9100-0100
Affected Serial Numbers: 075180 â€“ 084760
Defect: Turn on Unexpectedly
The company has identified two problems with the AEDs listed above. The defibrillators with serial numbers 075690 â€“ 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 â€“ 084760, involves the â€œON/OFFâ€� button. In some cases, the â€œON/OFFâ€� button of the device may become inoperative after the device turns on unexpectedly. The companyâ€™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.