HeartSine has notified that certain Samaritan 300/300P public access defibrillators (PAD) have been found to intermittently turn on and off, which may eventually deplete the battery. These devices are intended for use on patients experiencing sudden cardiac arrest.
In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. A device experiencing either condition could be unable to deliver therapy during a cardiac event.
Samaritan 300/300P PAD devices with the following serial numbers are affected by this recall:
- 0400000501 to 0700032917
- 08A00035000 to 10A0070753
- 10C00200000 to 10C00210106
According to the company, the affected devices were manufactured and distributed from 1 August 2004 to 31 January 2011.
HeartSine has communicated that it has issued a letter to customers on 11 September 2012 describing the problem and provided instructions for correction. HeartSine has requested that customers follow the instructions detailed in their letter to ensure that affected devices are able to provide therapy if a sudden cardiac arrest event occurs.
Healthcare professionals and patients are encouraged 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 Programme.