• Urgent Product Defect Correction: HeartSine® samaritan® Public Access Defibrillators (PAD)

TGA Ref: RC-2024-RN-00356-1

Medsafe Ref: 33029

ARTG: 156690, 228210

WAND: 180327-WAND-6Q1GLE, 180327-WAND-6Q1GMF  

HeartSine samaritan Public Access Defibrillators (PAD) are small, lightweight, portable, battery operated Automated External Defibrillators (AEDs) designed to treat victims of cardiac arrest.

A manufacturing related issue may impair device audio prompts.  Stryker is issuing a customer notification to remind customers to follow the User Manual and power the device upon receipt to ensure the audio prompts function as intended.

Additional maintenance instructions are being issued as a Maintenance Supplement to the User Manual. Stryker recommends that users complete an audio prompt check once every three months. This can be carried out quickly without removing the AED from its case. A copy of the Maintenance Supplement can be downloaded here.

In the event the device does not have any audio prompts, the user can still refer to the visual instruction icons and quick user guide to attempt treatment.

If you own a HeartSine samaritan PAD, please review and follow the instructions provided in the Australian or New Zealand Customer Notification Letters, as applicable.

Stryker, in consultation with the Therapeutic Goods Administration (AUS) & Medsafe (NZ), have initiated this corrective action.

For a copy of the Customer Notification Letter, or any questions relating to this notice, please contact Stryker’s Post Market team at or call on +61 2 9170 9162.

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About Bunzl Safety and Lifting

Bunzl Safety and Lifting offers an integrated approach to the selection, supply, service, and replacement of safety products, resulting in our ability to manage the complete life cycle of your personal and workplace safety requirements. Bunzl Safety and Lifting is a leading manufacturer of safety products, we provide the very best in workwear, corporate wear, PPE, footwear, materials handling, load restraint, and recovery,height safety, and site safety. We are also a leading supplier of some of the best industrial safety brands on the market, including Mack, Ninja, Contego, Boomerang, Beaver, B-Safe, WS Workwear, Frontier, Black Rat, Robertsons, 3M, Honeywell, Ansell, Bolle Safety, DuPont, Donaghys, MSA, Moldex, Steel Blue, Oliver, uvex, Sqwincher, MaxiFlex, DNC Workwear, Mayo Hardware, Gunnebo Industries, Skylotech and Blundstone. We also offer a range of services including product specialisation and consolidation, custom embroidery and branding, lifting equipment and inspections, NATA Accredited testing and services, height safety installed systems and training, managed inventory, eCommerce and digital solutions, clothing fitouts and yearly uniform issues, ethical sourcing, Indigenous Engagement, and environmental responsibility. We have an Australia-wide network of branches that ensures fast shipping across the country.

Bunzl Brands & Operations Pty Ltd (BBO) located at 55 Sarah Andrews Close Erskine Park NSW 2579 quality scope covers: manufacturing, importing, wholesaling, repairing and testing of lifting, rigging equipment, winches, hoists and materials handling products. The manufacture of synthetic slings and webbing products including load restraint and height safety equipment. Manufacture, import, wholesale and distribution of PPE products, workwear and hand tools. Design and development of products and services and the provision of mechanical testing services.