Reason/Issue |
HeartWare AC Adapters with serial numbers CAC000001 to CAC005796 are vulnerable to power grid surges above 220 volts. If an AC Adapter fails, the patient’s Controller will alarm and automatically switch to the other power source. If patients follow HeartWare’s Patient Manual, there are no elevated risks to health. However, if a patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a failed AC Adapter, the system could lose power, which may lead to serious injury or death.
In addition, there have been complaints related to earlier than expected battery depletion for batteries with serial numbers BAT000001 to BAT199999. Premature or unrecognised battery depletion may pose a risk to the patient, if the patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a depleted battery. |