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.

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

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