Agency classClass IOur severity:Severe FDA (Devices)·Z-0124-2013·Announced 2012-11-07

HeartSine Samaritan 300/300P PAD Devices Recalled for Malfunction

Heartsine is recalling 81,982 Samaritan 300/300P PAD devices because they may turn on or off unexpectedly, potentially preventing therapy delivery during cardiac arrest.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class I recall, which by rubric criteria mandates a minimum score of 4. The hazard involves a medical device failing to deliver life-saving therapy during a cardiac arrest.

Plain-English summary

Heartsine Technologies, Limited is recalling approximately 81,982 HeartSine Samaritan 300/300P PAD devices. These automated external defibrillators (AEDs) are indicated for use on victims of sudden cardiac arrest. The recall covers devices with serial numbers 0400000501 to 0700032917, 08A00035000 to 10A0070753, and 10C00200000 to 10C00210106.

The recall is due to a defect where the device may turn itself on and off without user input. This malfunction could affect the device's ability to deliver therapy to a patient in a sudden cardiac arrest event if needed. The source text notes that when this occurs, the normal sequence of audible instruction prompts may be emitted.

The affected devices were distributed worldwide and nationwide in the United States, including in Alaska, Alabama, American Samoa, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. Consumers should check their device serial numbers and contact Heartsine for instructions on replacement or repair.

The recalled product

Product: HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following…
Manufacturer: Heartsine Technologies, Limited
Category: Medical Device — Automated External Defibrillator (AED)
Hazard: device-malfunction
failure-to-deliver-therapy
Affected units: 81,982

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Serial numbers 0400000501 to 0700032917
08A00035000 to 10A0070753
10C00200000 to 10C00210106

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Same manufacturer · Heartsine Technologies, Limited

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FDA (Devices) · 2014-07-30

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