U.S. Health Regulators warned today that <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">Philips Lifeline Personal Help Buttons can pose a choking hazard. According to a notice posted on the Food & Drug Administration (FDA) website, there have been at least six reports between 1998 and 2009 of serious injury or death, including three deaths in the United States and one in Canada, from choking after the cord on the Philips Lifeline Personal Help Button became entangled on other objects worn around the neck.
According to Philips Lifeline, the device is used primarily by seniors living independently, who feel they are at risk for falls or other medical emergencies. By pushing the â€œhelpâ€ button on the device when in distress, users can call for emergency assistance to their home.
The Lifeline pendant button is intentionally designed to not break away when tugged, which prevents the button from accidentally falling off. However, because it does not break away, there is a risk of choking, including the possibility of serious injury or death. Risks are greater for those with mobility limitations or for those who use wheelchairs, walkers, beds with guard rails, or other objects that could entangle with a neck cord.
According to the FDA, there are more than 750,000 users of these devices in the United States and Canada. While the number of adverse events reported is small compared to the number of people who use the Philips Lifeline Personal Help Button, the severity of these events is of concern. It remains important that users, along with their health care providers, assess the options provided by each style of button, and choose the option that best fits their condition.
Philips Lifeline is currently sending letters to its 750,000 customers and has changed the labeling of this product to include a warning against the potential choking hazard. The FDA recommends that users consult their health care providers to determine which style of emergency button, including those that are worn on the wrist, is most beneficial for them.