| TGA Action ID |
RC-2025-RN-00740-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
HeartSine Pad-Pak used with HeartSine SAM 350P, HeartSine SAM 360P, HeartSine SAM 500P
Pad-Pak Catalogue Numbers: PADPAK03, PADPAK04, PADPAK07
HeartSine Catalogue Numbers: 350BASUK10, 360BASSJ10, 360BASUK10, 500BASUK10, 500BASUKGW
Expiry dates: 17 April 2025 to 01 August 2029 |
| ARTG Number |
312730, 338960 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
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.
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.
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. |
| Instructions for Customers/Users |
End users and distributors are to:
- Inspect any Pad-Paks on hand to determine if the expiry is between 17 April 2025 to 01 August 2029.
- If within the expiry date range follow the instructions in the customer letter and remove the Pad-Pak and check for bent locator pins.
- If locator pins are straight, re-insert the Pad-Pak correctly.
- If the locater pins are bent, remove that Pad-Pak and set it aside.
- If the locater pins are bent, Stryker will provide replacement Pad-Paks, once the response form is received.
Further instructions are provided in the customer letter. |
| Action Commencement Date |
17/09/2025 |
| Responsible Entity |
|
| Contact Information |
padpak.ssp@stryker.com - Stryker Australia |