Urgent Field Safety Notice affecting Heartsine AED’s

Stryker have issued a field safety notice affecting Heartsine AED’s (April 2024)

Product description The HeartSine Samaritan PAD and Omron HDF-3500 are small, lightweight, portable, battery operated Automated External Defibrillators (AEDs) designed to treat victims of cardiac arrest.

Product issue Stryker have determined that a manufacturing related issue may impair device audio prompts in some affected units. Stryker is issuing a customer notification to remind customers to follow the User Manual and power the device upon receipt to ensure the audio voice prompts function as intended.

Potential risks The issue could prevent the device from delivering instructional voice prompts to the user during use of the device. The device has visual instructional icons still present and is functional, but if the issue is not identified by the customer prior to use, it could potentially lead to no therapy or a delay in therapy. In addition, there may be risk of shock to the user due to the absence of the “stand clear” voice prompt. There has been one reported serious incident to date in which the device failed to deliver audio prompts. Serious incidents or quality problems experienced with the use of this product may be reported to the Stryker Representative.

Please download RA2024-3540155 FSN UK and Ireland to find more information.

HeartSine Samaritan PAD 360P Fully-Automatic Defibrillator
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