Critical product correction

PAD-PAK BATTERY

for HeartSine® samaritan® Public Access Defibrillator (PAD)

Product description:

The Adult and Paediatric Pad-Paks, used with the HeartSine® samaritan® Public Access Defibrillator (PAD), contain a battery to power the defibrillator, and two electrode pads to provide defibrillation to a patient in cardiac arrest.

 

Product affected:

 

Padpak battery image
imge of paediatric padpak
Padpak table2

If the Pad-Pak is installed in a HeartSine AED, turn the device over and check the back.

The expiry date can be found on the rear of the Pad-Pak. 

Padpak rear

Product problem:

Post-market surveillance has revealed that the Pad-Paks are not always inserted properly into the HeartSine® samaritan® PAD devices as outlined in the User Manual, which can create failure during device use. In the event the device is unable to complete connection, the device will repeatedly prompt, “apply pads to patient’s bare chest.” In some cases, the AED may fail to power on entirely.

Upon investigation, two potential causes of the improper insertion of Pad-Paks include use error and bent locator pins, which may occur during the manufacturing process.

 

Potential risks:

The connection problems that may arise from improper insertion of the Pad-Pak are not always obvious to the user when the Pad-Pak is inserted into the HeartSine® samaritan® PAD device. If the Pad-Pak is not properly inserted into the HeartSine® samaritan® PAD device, or if the Pad-Pak locator pins are bent, the device may fail to deliver the intended therapy during use, potentially leading to a delay in treatment or no treatment being delivered during use. A delay in treatment or no treatment may result in serious injury or death.

 

What should I do:

If you have Pad-Paks within the expiry date range:

1. Visit the website to complete your Acknowledgement form: https://heartsinerecall.com/HeartSineSamaritanPAD/LookUp

2. Remove Pad-Pak and check for bent locator pins,

PP pin image
PP correct
pp incorrect

* If locator pins are straight, re-insert the Pad-Pak following the User Manual and continue to use the HeartSine samaritan PAD.

* If the locator pins are bent, remove that Pad-Pak from the HeartSine samaritan PAD, set it aside and contact Stryker on 02 8413 1250 or email padpak.ssp@stryker.com to organise replacement Pad-Paks.

* Once you receive the replacement Pad-Pak/s, please dispose of the affected Pad-Pak/s.

 

If you have any questions, please contact Stryker on 02 8413 1250 or email padpak.ssp@stryker.com