Recall issued for public access defibrillators
October 07, 2013
HeartSine Technology has voluntarily recalled its Samaritan 300/300P public access defibrillators, and the U.S. Food and Drug Administration has advised of the recall through its MedWatch safety alert system.
The recall advises of two separate issues that may cause malfunctions in some of HeartSine Technology's Samaritan 300/300P PAD devices, which may consequently fail to deliver therapy to a patient in a sudden cardiac arrest event.
One issue is that some of the devices manufactured before December 2010 intermittently switch on and off, potentially depleting the device's battery. The other issue is some of the devices contain early versions of battery management software that may cause the devices to shut off when they misinterpret a temporary drop in battery voltage as signaling a low battery charge. Either condition could cause the devices to be unable to deliver therapy during a cardiac event.
One or both of these issues may affect Samaritan 300/300P PAD devices with the following serial numbers:
- 0400000501 to 0700032917
- 08A00035000 to 10A00070753
- 10C00200000 to 10C00210106
Dentists and other health care professionals who have Samaritan 300/300P PAD devices with these serial numbers should contact HeartSine Technologies for a free upgrade kit. Email email@example.com or call 877.877.0147.
The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Call the FDA at 800.332.1088 to request a reporting form, or complete and submit a form at www.fda.gov/MedWatch/report.htm.