HeartSine issues Class I recall of defibrillators

HeartSine has notified customers that certain Samaritan 300/300P public access defibrillator (PAD) devices have been found to intermittently turn on and off, which may eventually deplete the battery. Thus, the company is issuing a Class I recall of the devices.

Samaritan 300/300P PAD 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, according to the recall notice, posted on the FDA site Nov. 19. A device experiencing either condition could be unable to deliver therapy during a cardiac event.

The Samaritan 300/300P PAD devices with the following serial numbers are affected by this recall:

  • 0400000501 to 0700032917
  • 08A00035000 to 10A0070753
  • 10C00200000 to 10C00210106

The company said the affected devices were manufactured and distributed from Aug. 1, 2004, through Jan. 31, 2011.

The company issued a letter to customers on Sept. 11, describing the problem and provided instructions for correction. Newtown, Pa.-based HeartSine has requested that customers follow the instructions detailed in their letter dated Sept. 11, to ensure that affected devices are able to provide therapy if a sudden cardiac arrest event occurs.