Urgent Product Safety Action

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

Step 1: Identify Device Serial Number

We need you to identify if you have any of the devices with affected serial numbers listed just below. To be able to find your device serial number, see the labels on the rear of your device as shown in the image above.

Device serial numbers consist of a 2-digit prefix, device model code and 8-digit serial number string.

The prefix (device identifier) consists of the manufacturing year (YY) and the device model (B, C, D, E, G, or H) like the following example serial number: 16B00001234

Devices affected by this Urgent Product Safety Action begin with 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

Step 2: Check the Pad-Pak

If your device fails to power up, please check the expiration date (YYYY-MM-DD) on the rear of the Pad-Pak as shown.

If the expiration date has lapsed, do not reinsert it and immediately replace the expired Pad-Pak with a new unit if one is at hand.

Follow the next step on how to replace the expired Pad-Pak unit.

Step 3: Replacing the Pad-Pak

Place the HeartSine Samaritan PAD face up on a flat surface and slide the Pad-Pak into the HeartSine Samaritan PAD until you hear the “double click” to indicate that the tabs on the right and left sides of the Pad-Pak are fully engaged.

Verify that the green Status indicator is blinking to indicate the initial self-test routine has been performed and the device is ready for use.

Press the green On/Off button to turn on the HeartSine Samaritan PAD. Listen for, but do not follow, the voice prompts to ensure you can hear the prompts and no warning messages are played.
a) If you hear the message “Adult patient” or “Call for medical assistance”, no further action is needed.

If you don’t hear a warning message and the status indicator continues to flash green, the device is ready for use.

We recommend you carry out this check (Step 2 and 3) once every three months. This can be carried out quickly without removing the AED from its case.

Urgent Safety Action Form

However, please only complete this form if you DO NOT HEAR an audio prompt from your device even after replacing the Pad-Pak unit.