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Physio-Control LIFEPAK 500 AED
The International Association of Fire
Fighters has received a report regarding an explosion from
an automatic external defibrillator (AED) commonly used by
the fire and emergency services.
On Friday, October 15, 1999, a Physio-Control
LIFEPAK 500 exploded and injured two firefighters. The
incident occurred at the Okaloosa Island Fire Department
located in the panhandle of Florida. A second unit was found
to have exploded in a vehicle in the small rural community
of Red Bay in Walton County. The second explosion occurred
sometime between October 12 and October 15 and was not
discovered until reports of the Okaloosa Island explosion
reached the Fire and EMS community in the State of Florida.
In the Okaloosa Island Fire
Department, the AED unit is inspected each morning during
the routine vehicle check. On the morning of the incident,
the driver of the vehicle activated the unit; the visual
readout flashed on and then quickly shut off. He then
attempted to reactivate the unit, which resulted in no
visible readout. The driver then brought the unit into the
station and reported the problem to the shift captain and
the assistant chief. The assistant chief attempted to
activate the unit, which resulted in a readout of "replace
battery". The assistant chief then asked the shift captain
to contact the county EMS agency to request a new battery.
The captain then set the unit on a desk in the watch office.
He removed the battery, reinserted it, and turned the unit
on. The unit displayed a readout of "self test". The
assistant chief entered the office and the captain then
turned the unit off. The assistant chief pulled the battery
from the unit believing it was not installed properly. The
battery was then reinserted and when the assistant chief
activated the unit an explosion occurred. The bottom of the
AED unit was blown apart with plastic shrapnel propelled
about the office. The assistant chief was thrown out the
office door about 8 feet by the force of the explosion. The
captain was forced against the office wall and a computer
desk. Both inhaled fumes from the explosion, which caused
eye, throat and lung irritation and the assistant chief
suffered a burn on his hand from the heat of the blast.
The fire fighters were treated by
other shift personnel and then transported to the hospital
by Okaloosa County EMS where they were treated and released.
Okaloosa Island Fire Chief James Hooks contacted the State
Fire Marshals Office and requested assistance to investigate
the explosion.
After the Fire Marshals Office
released a notice of the incident, a volunteer fire fighter
in the Red Bay community of Walton County inspected their
LIFEPAK 500 unit. Upon inspection, he found that their AED
unit had exploded as well. The AED unit was destroyed, with
the same characteristics found in the Okaloosa Island Fire
Department explosion. There was slight damage to the vehicle
where the unit was stored, but there were no injuries with
this incident.
Local Physio-Control representatives
informed area departments that over 25,000 units were in
service and that this was the first time such an incident
had occurred. They informed local fire and emergency
personnel that they felt the unit was safe and advised that
they not be removed from service. The corporate offices of
Physio-Control informed its customers yesterday (see
http://www.Physio-Control.com/lithiumbattery.html)
that there have been four documented cases of "sudden
venting" of lithium batteries--including the Okaloosa Island
Fire Department incident. They are recommending that these
devices remain in service while they evaluate these events.
The International Association of Fire
Fighters is concerned with the potential of further injuries
of fire fighters and emergency medical personnel when using
such AEDs and with the potential of injury to patients being
treated with these life-saving devices. Unlike prior
research in battery explosions with equipment (e.g.
flashlights) using zinc/carbon and alkaline batteries, we
understand these AEDs use lithium batteries.
Accordingly, the International
Association of Fire Fighters has formally requested that
NIOSH, through its Division of Safety Research, provide the
IAFF technical assistance by investigating these incidents,
as well as conducting any needed independent research on the
potential safety hazards of such rechargeable and
nonrechargeable (lithium battery) Automatic External
Defibrillators. Additionally, we requested that a fact sheet
be prepared and distributed to workers and their employers
using this equipment, similar to the NIOSH Fact Sheet
Exploding Flashlights: Are they a Serious Threat to Worker
Safety.
Additionally, as the IAFF did with the
LSP oxygen regulator incidents, we simultaneously requested
the Food and Drug Administration to be involved in this
investigation process. We asked the FDA, through its
compliance offices within the Center for Devices and
Radiological Health, to assist in the NIOSH investigation
and conduct any needed independent research on the potential
safety hazards of rechargeable and nonrechargeable (lithium
battery) Automatic External Defibrillators as well as to
initiate any product recalls.
Additionally, the IAFF is asking our
membership that has experienced similar problems with
Physio-Control AEDs to report such incidents to the U.S.
Food and Drug Administration’s Medical Products Reporting
Program (MedWatch) through FDA Form 3500A. Form 3500A and
the respective instructions can be downloaded here.
Additional information regarding medical device reporting
can be searched from the
FDA’s
web page. All IAFF affiliates
are encouraged to report any difficulties with medical
devices to the FDA and to the IAFF Department of
Occupational Health and Safety.
If your department uses these AEDs, be
advised that they should be checked immediately.
Updates will be provided as this
investigation continues.
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