Safety warnings issued on HeartSine’s public cardiac defibrillators

Health officials in the U.K. have issued a public safety alert regarding potentially defective cardiac defibrillator that could cause serious injuries or death to those who may require the services of this device.

According to information provided by U.K.’s Medicines and Healthcare Product Regulatory Agency (MHRA), the action being taken this week involves specific models of the Samaritan public access defibrillator manufactured by HeartSine Technologies Ltd. Specifically, the notice involves the Samaritan PAD 300/300P distributed from August 2004 until December 2010. These defibrillators have a warranted life of up to seven years.

These defibrillators are commonly found in public areas and are designed to be used in an emergency in lieu of other immediate medical attention.

MHRA has identified two problems with the affected defibrillators that forced its hand in issuing this safety alert. First, some defibrillators may repeatedly turn on and off when they’re not in use. This can lead to unexpected battery depletion and in doing so, could cause the defibrillator to not work when a person expects or needs it to function.

Secondly, the defibrillators with early versions of the battery management software may switch off after delivering the shock it’s designed to deliver. It could also cause the defibrillator to give a user a “premature low battery warning.”

The agency recommends that community defibrillation officers and others responsible for these devices in their specific settings should be on the lookout for potential signs of these devices being defective. They should first identify any devices that are currently accessible to the public that are covered by the limits of this MHRA action.

Next, these officers and other personnel should ensure that the defibrillators are working on a daily basis, or to at least increase the frequency at which they check on these typically dormant devices. The defibrillators should be moved to an area where they’ll be noticed more often so that if a defect occurs, it is noticed and remedied promptly. According to the safety notice, the if the LED on the defibrillators is red or unlit, that person in charge of the unit should contact HeartSine Technologies immediately to receive a replacement device.

HeartSine indicates that it will send replacement devices for those affected by this safety announcement. It will also send out software and other hardware upgrades that should eliminate the risk posed by these defects. MHRA recommends that health care professionals in the U.K. take notice to this action and be sure to identify any potential affected defibrillators at their facilities.

These devices were also distributed to home care clinics, hospitals, and to private physicians across the U.K., according to the agency.


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