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Urgent Product Safety Action

HeartSine Samaritan 350P, 360P, and 500P Audio Prompts Not Working

Urgent Safety Notice for HeartSine Samaritan Defibrillators

This important safety update page for owners and operators of HeartSine Samaritan 350P, 360P, and 500P defibrillators identifies a critical issue where the audio prompts intended to guide you during emergencies may not function properly. This page provides comprehensive steps to help you determine if your device is affected based on its serial number, along with detailed instructions for checking and replacing the Pad-Pak if necessary. Ensuring the operational readiness of your defibrillator is crucial, and we urge you to follow the outlined procedures to maintain the safety and effectiveness of your life-saving equipment.

 

Step 1: Identify Device Serial Number

Please identify if you have any of the following devices with affected serial numbers. Check the labels on the rear of your device for the serial number, which includes a 2-digit prefix, device model code, and an 8-digit serial number string. For example, a serial number might look like this: 16B00001234.

Devices affected by this Urgent Product Safety Action have the following prefixes and device codes:

16B, 16C, 16D, 16E, 16G, 16H
17B, 17D, 17E, 17G, 17H
18B, 18D, 18E, 18G, 18H
19B, 19D, 19E, 19G, 19H
20B, 20D, 20E, 20G, 20H
21B, 21D, 21E, 21G, 21H
22B, 22D, 22E, 22G, 22H
23B, 23D, 23E, 23G, 23H
24B, 24D, 24E, 24G, 24H

heartsine defib
pad pak

Step 3: Replacing the Pad-Pak

To replace the Pad-Pak:

  1. Place the HeartSine Samaritan PAD face up on a flat surface.
  2. Slide the Pad-Pak into the PAD until you hear a “double click” indicating full engagement of the tabs on both sides.
  3. Check that the green Status indicator is blinking, confirming the device has performed its initial self-test and is ready for use.
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Step 2: Check the Pad-Pak

If your device does not power up, check the expiration date on the rear of the Pad-Pak. Do not reinsert an expired Pad-Pak. Replace it immediately with a new unit, if available.

heartsine defib

Step 4: Test the device

Press the On/Off button to turn on the HeartSine Samaritan PAD:

  1. Place the HeartSine Samaritan PAD face up on a flat surface.
  2. Listen for, but do not follow, the voice prompts to ensure you can hear the prompts and no warning messages are played.
    • If you hear the message "Adult patient", or "Call for medical assistance" no further action is needed.
  3. If you do not hear a prompt:
    • Please remove the device from use and segregate it immediately.

Step 5: Complete the Form Below

Regular Checks

We recommend conducting these checks (Steps 2 and 3) once every three months. These checks can be done quickly without removing the AED from its case.

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Talk to Dave

Managing Director

David established HeartSafety Solutions in 2006 with the aim of improving survival from sudden cardiac arrest (SCA). As a former firefighter/ Paramedic, he witnessed too many incidents of SCA where help arrived too late and knew things could be so much better. The following year HeartSafety launched the GAA National Defibrillator programme, which resulted in the placement of AEDs in most towns and villages around Ireland. David is a qualified Paramedic Tutor, Basic Life Support instructor and a member of IOSH having completed a HDip in Health & Safety from UCD.