According to the latest news from pharmaceutical and medical device sector, the FDA has slapped “HeartSine” one of the pioneers of clinically advanced automated external defibrillators (AEDs) with a class I recall. According to sources the recall was issued by the FDA for some Samaritan model 300/300p public-access defibrillators. Class I recalls are issued to drugs and medical devices for having some serious and dangerous defects that could cause some serious health problems to people even death. Some of the examples where the federal agency could issue a class I recall include food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.

The move was taken by the FDA following the release of the company’s “global-correction” letter in the month of September that described the problem and its recommended fixes. In the letter the agency has said that the manufacturer, HeartSine is recalling it’s certain Samaritan 300/300p PAD devices that have been found to turn intermittently on and off that may ultimately deplete the battery. The agency has also confirmed that certain Samaritan 300/300P devices are installed with early version of battery management software that may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. In either of the cases it couldn’t be possible for the device to deliver appropriate 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

Affected devices were manufactured and distributed from 08/01/2004 to 01/31/2011.

What is Samaritan 300P PAD Public Access Defibrillator?

The Samaritan 300P PAD Public Access Defibrillator (or Automatic External Defibrillator) is an easy-to-use medical device especially designed for public access use, to administer lifesaving treatment for Sudden Cardiac Arrest. No complex displays or controls. A flashing green STATUS light indicates system is operational.

Some of the features of Samaritan 300P PAD Public Access Defibrillator:

  • The samaritan PAD 300P with industry exclusive SCOPE biphasic waveforms is the most portable & lightweight unit which is compliant with AHA 2010 guidelines.
  • Battery& electrode pads are incorporated in the innovative PAD-PAK™.
  • Warranties: Samaritan PAD 300P – 10 years, PAD-PAK™ – 4 years from date of manufacture.

 

About HeartSine

HeartSine® is one of the renowned names in the field of clinically advanced automated external defibrillators (AEDs) for the workplace, public access and home markets. The company claims that almsot every AED in use today can trace its roots to technology envisioned and developed by HeartSine technologists. The company takes pride in being the only manufacturer of automated external defibrillators whose roots date back to the development of the world’s first truly portable, battery-operated defibrillator.