Software and hardware problems are reportedly causing failures in EnVe Ventilators, leading to a recall due to the risk of serious injury or death.
The FDA announced a Class 1 medical device recall for 128 EnVe ventilators on October 19, after discovering the manufacturer, Carefusion, sent a recall notification to customers (pdf) last month.
According to the FDA and Carefusion, the ventilators may unexpectedly reset, disconnect upon transport or suffer a delay in resuming ventilation after reconnection.
The problems could lead to a patient suffering hypoxia or hypercarbia, which could cause serious neurological damage or death. A Class 1 medical device recall designation is reserved for defective devices that the FDA believes have a high probability of causing severe injury or death.
The recall affects 128 EnVe Ventilators manufactured between December 2010 and May 2011. A full list of serial numbers of devices affected by the recall is available in the Carefusion letter to customers.
According to Carefusion, in Non-Invasive Ventilation (NIV) mode when the mask is removed from the patient, the EnVe ventilator will issue an alarm to let the healthcare professional know that ventilation has been interrupted. The company suggests that the healthcare professional put the ventilator into Standby mode, re-attach the mask to the patient and press Ventilate on the device’s display screen to resume ventilation.
There are also cases where the ventilator may go from operational to reset condition, interrupting ventilation to the patient. This will cause an audible alarm and visual alarm indicator on the ventilator screen.
In some cases the ventilator will go to Intermittent Reset and resume normal ventilation, at which point the healthcare professional can push alarm reset in the Alarm Messages tab on the ventilator display to clear the display. If the ventilator goes to Continuous Reset and does not resume normal ventilation, the healthcare provider should find an alternative method of ventilation for the patient.
The third problem occurs when the ventilator patient circuit is disconnected from the device patient circuit port. This will also interrupt ventilation to the patient. When a disconnect occurs, there will be a Patient Circuit Fault Alarm triggered on the Ventilator display panel. Healthcare providers should securely reconnect the patient circuit to the ventilator Inspiratory or Expiratory port. Ventilation should resume and the healthcare professional can push alarm reset in the Alarm Messages tab on the ventilator display to clear the display.
All registered customers who received the devices have been notified by Carefusion.
Tags: Medical Device