Urgent Product Safety Action
HeartSine samaritan 350P, 360P and 500P Audio prompts not working
Stryker have determined that a manufacturing related issue may impair device audio prompts. The issue could prevent the device from delivering instructional voice prompts to the user during use of the device. The device has visual instructional icons still present and is functional, but if the issue is not identified by the customer prior to use, it could potentially lead to no therapy or a delay in therapy.
Step 1- Identify the Device Serial Number
We need to determine if your device is affected. We do this by looking at the serial number and checking if it is included in the list of affected devices.
To find your serial number please look at the labels on the rear of your device as shown in the image (right).
Device serial numbers consist of the manufacturing year (YY), device model code (B, C, D, E, G or H) and an 8 digit serial number string ie 20D12345678.
If your device is in the list please follow the instructions below to check your device delivers audio prompts.
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
Step 2 - Check the Pad-Pak
Check the expiration date (YYYY-MM-DD) on the rear of the Pad-Pak by pulling the green tab. If the expiration date has passed, do not use and immediately replace the expired Pad-Pak.
Follow the next step on how to replace the Pad-Pak unit.
Step 3 - Replace 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 On/Off button to turn on the HeartSine Samaritan PAD.
Step 4 - Press the 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.
If you hear the message “Adult patient,’’ or ‘’Call for medical assistance’’ no further action is needed.
If you do not hear a prompt: Please remove the device from use, segregate it immediately and complete the form below.
Complete this form ONLY if you do not hear a prompt