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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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