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Medical Devices

Philips Lifeline Personal Help Button: FDA Safety Communication

Date: September 21, 2009

On September 11, 2009, Philips Lifeline (111 Lawrence Street, Framingham, Massachusetts 01702) issued a Press Release and important Safety Notice to owners/caregivers about their Lifeline Personal Help Button.

Philips Lifeline Personal Help Button is primarily used by seniors living independently in their homes. This device connects users to a remote monitoring center staffed 24 hours a day. The Lifeline Personal Help Button can be worn as an adjustable neck cord or wrist strap.

Philips Lifeline has received several reports of incidents where users' neck cords became accidentally entangled, causing either injury or death. These pendant neck cords are not designed to break away. If the neck cord becomes entangled on another object while worn by the user, there is a risk of choking.

With Lifeline's Slimline Wristband and Tempo Watch, there may be situations where the user's arm that is not wearing the Wristband or Tempo Watch becomes immobilized (due to a stroke or their arm being trapped under a heavy object), that can present a risk that the user will be unable to press the button.

Lifeline has asked users of these services to consult with their caregivers or the company at 1-800-852-5433 (Monday-Friday, 8AM-8PM, Eastern Time) to determine which style of help button is most appropriate for them.

For additional information, please see Philips Lifeline's Press Release at http://www.lifelinesys.com/ content/company/index.jspExit Disclaimer (click on Lifeline issues safety notice to subscribers) and their caution notice at http://www.lifelinesys.com/ content/lifeline-products/slimline.jspExit Disclaimer

Page Last Updated: 10/06/2014
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