This text below is from Stryker:

Stryker has initiated a Critical Product Correction for the Pad-Pak battery and electrode pack (Pad-Pak) which may be installed in HeartSine samaritan PADs (HeartSine AED). This product correction is being issued to notify customers with HeartSine Pad-Paks with expiry dates between 17 April 2025 – 01 August 2029, to check for bent locator pins, and to ensure the Pad-Pak is correctly inserted into the HeartSine AED.

Product description
The HeartSine Pad-Pak is a combined battery and electrode cartridge designed for use with the HeartSine AED. Each Pad-Pak is a single-use cartridge that powers the HeartSine AED and contains a pair of electrode pads to connect to and provide defibrillation to a patient in cardiac arrest.

Product problem
Post-market surveillance has revealed that the Pad-Paks are not always inserted properly into the HeartSine AEDs as outlined in the User Manual, which may cause failure during device use. Upon investigation, the potential causes of the improper insertion of Pad-Paks include user error and bent locator pins, which may occur during the manufacturing process. In the event the device is unable to complete electrical connection via the pins, the device will repeatedly prompt “apply pads to patient’s bare chest”. In some cases, the HeartSine AED may fail to power on entirely.

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Potential hazards and harms
If the Pad-Pak is not properly inserted into the HeartSine AED, 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.

Complaint Information
Since 2018, there have been 36 adverse events reported globally. Of these, 5 were confirmed to be caused by bent locator pins, 2 devices were not returned for investigation and 29 were determined to be related to potential user error. These figures represent global data and are not specific to Stryker Australia Pty Ltd.