Issues have been highlighted with the HeartSine Samaritan PAD, Omron HDF-3500 automated external defibrillators (AEDs), and the Philips Heartstart intrepid monitor/defibrillator.
The HeartSine Samaritan PAD and Omron HDF-3500 are small, lightweight, portable, battery-operated AEDs designed to treat cases of cardiac arrest. The production company, Stryker, have determined that a manufacturing related issue may impair device audio prompts.
This could prevent the device from delivering instructional voice prompts during use of the device. Stryker are notifying all customers that have one of these devices within the identified range of potentially affected devices to perform the actions outlined.
In addition, Philips has become aware of a potential safety issue where the HeartStart Intrepid Monitor/Defibrillator may display intermittent ECG waveforms when the fourth limb lead is placed on the patient using either a 5-lead or ten-lead ECG cable.
All HeartStart Intrepid Monitor/Defibrillators may be affected by this issue. Information has been released about the actions that should be taken by the customer or user to prevent risks for patients or users.