date: 27/11/2025
The medical devices HeartSine samaritan PAD models SAM 350P/360P/450P/500P, as well as the HeartSine samaritan Pad-Pak and Paediatric-Pak units, are subject to two safety actions due to potential malfunctions or failures of certain defibrillators and accessories.
- The first safety action (Field Action FA318) concerns the HeartSine samaritan PAD SAM 350P/360P/450P/500P defibrillators. Their manufacturer, HeartSine Technologies Ltd/Stryker, has identified a manufacturing problem that poses a risk of malfunction, and the defibrillator may not work. The manufacturer will replace the affected devices.
- The second safety action (Field Action A327) concerns the HeartSine samaritan Pad-Pak and Paediatric-Pak accessories. HeartSine Technologies Ltd/Stryker has found that the HeartSine samaritan PAD defibrillator may not work if the Pad-Pak or the Paediatric-Pak are not properly inserted, due to user error or bent locator pins. The manufacturer recommends checking the devices and following the installation instructions carefully.
The first safety action only involves certain defibrillators with specific serial numbers; hence it is possible that the manufacturer or distributor informed users of the devices about the second safety action only. Please find more information on the manufacturer's website, by entering the serial number of your device. If in doubt, the FAMHP recommends contacting the manufacturer or distributor.