Lifesaving Resources has received an urgent recall notice for all Access CardioSystems’ Access AED and Access ALS Automated External Defibrillators.
Access CardioSystems has become aware of two potential issues involving certain AEDs that warrant your immediate attention. The following is a description of each potential issue followed by instructions for discontinuing use of all your Access CardioSystems AEDs.
Potential Failure Of The Shock Delivery Circuit
The Company has become aware of a situation involving certain of its AEDs in which the device may experience a catastrophic failure of the shock delivery circuit. The Company’s investigation indicates to date that this failure mode is restricted to a specific batch of one device component. 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 0.8% complaint rate within the affected units). When this potential problem occurs, it is not possible to deliver additional defibrillation shocks.
Although the investigation of this issue is still ongoing, the Company has determined that AEDs with the following serial numbers may have this problem:
AccessAED, AccessALS
Catalog Number 9100-0100
Affected Serial Numbers: 075690 – 077140
Potential Of The AED To Turn On Unexpectedly
The Company has also become aware of a situation involving certain of its AEDs in which 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.
Although the investigation of this issue is still ongoing, the Company has determined that AEDs with the following serial numbers may have this problem:
AccessAED, AccessALS
Catalog Number 9100-0100
Affected Serial Numbers: 075180 – 084760
Please immediately discontinue use of and remove from service Access CardioSystems AED Devices with the above referenced catalog and serial numbers.
Important: Certain of the AccessAED or AccessALS AEDs in your possession may have one, both, or neither of the issues described above. However, Access CardioSystems has made a business decision, effective November 3, 2004, to discontinue manufacturing and marketing ALL models of its AEDs and to discontinue supporting its AEDs that are currently in the field. The Company is no longer accepting orders for disposable parts used with their AEDs. Therefore, when your supply of disposable parts is depleted, please immediately discontinue use of and remove from service all of the Company’s AEDs that you have in your possession. It is your responsibility to equip yourself with AEDs that meet your medical needs.
For additional information, contact:
150 Baker Ave. Ext.
Suite 108
Concord, MA 01742
Off: 978/371-4985
Fax: 978/318-9258
Courtesy of LIFESAVING RESOURCES INC.