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NousDefionsDoc
11-08-2004, 13:11
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,
Access CardioSystems, 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, the company, 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, please contact the company as
follows:

Access CardioSystems
150 Baker Avenue Suite 108
Concord, MA 01742
Office: 978/371-4985
Fax: 978/318-9258

vsvo
11-08-2004, 19:44
NDD, thanks for the info. We just recently completed CPR-certification for the office (via American Heart). The instructor demo'd an AED and strongly suggested we purchase one, given how dummy-proof and more effective it was than just CPR. I'll make sure to research the choices more closely.

casey
11-10-2004, 12:31
NDD - sorry brother, I just got to this thread. There have been three incidents with the AED's thus far- two caught fire and one exploded. Near as can be determined all incidents were caused by off gasing by the batteries in a confined non-ventilated storage case (pelican etc). This off gasing combined with an auto start in the confined area caused the incendiary or flash effect. So make sure these are not stored in an air tight case.

The Reaper
11-10-2004, 12:41
NDD - sorry brother, I just got to this thread. There have been three incidents with the AED's thus far- two caught fire and one exploded. Near as can be determined all incidents were caused by off gasing by the batteries in a confined non-ventilated storage case (pelican etc). This off gasing combined with an auto start in the confined area caused the incendiary or flash effect. So make sure these are not stored in an air tight case.

Sounds like a Lithium or Lead Acid battery outgassing Hydrogen. Could make life interesting for a few seconds. Might be a serious problem in a flammable or enclosed location, like in an aircraft.

Good info casey, thanks!

TR