Safety Alert - Physio Control AED

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http://www.iaff.org/iaff/Health_Safety/safety_alert.html

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 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 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 such rechargeable 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

<http://www.fda.gov/cdrh/mdrforms.html > . 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.