In August 2023, FDA recall was published, due to a defect in emergency drive of the Cardiohelp console.
In some units. emergency drive may get stuck.
In situations where the emergency drive is required, a clinician may encounter difficulty turning the handle to operate the pump or may not be able to turn it at the required speed to adequately support the patient. If such challenges arise, the patient may experience a loss of sufficient hemodynamic support or gas exchange, leading to potential consequences like ischemia, hypoxia, stroke, or even death.
The measures to be taken are: Promptly inspect your existing inventory to identify any CARDIOHELP Emergency Drives that may be affected, notify Getinge immediately and ensure that an alternative emergency support method is readily available at all times.
