Class I - Dangerous
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
HeartSine Technologies
Class I - Dangerous
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Class I - Dangerous
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.
Class I - Dangerous
Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.
Class I - Dangerous
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.