Urgent Medical Device Correction.

Under the circumstances of the software anomaly during open suctioning, reconnection of the patient is not recognized by the ventilator and ventilation is not re-initiated. The user will always be present during the suction maneuver.  

The user will wait for the automatic re-initialization of ventilation. It may take a certain amount of time for them to realize that this does not happen. After that, the user may not be able to manually re-initiate ventilation in due time as per one of the 4 ways described above. If this is the case, they might decide to ventilate the patient by alternative means. 

Occurrence of this software anomaly may result in prolonged duration of the suction maneuver associated with a loss of ventilation until the user recognizes and takes steps to resolve the issue by manually bagging or placing the patient on an alternative ventilation device.

Compromised or stopped ventilation may result in interruption and/or loss of ventilation which may lead to hypoventilation, hypoxemia, bradycardia, hypercarbia, and/or increased intracranial pressure. Depending on the individual patient and the specific situation, the occurrence of the software anomaly could potentially result in apnea and/or death in the most vulnerable patients.

By filling out the form below, I confirm that I have received and noted this Medical Device Correction, stating that the HAMILTON-C6 ventilator is affected by a software anomaly during open suctioning. I will follow the instructions regarding the malfunction. 

The entire Medical Device Correction can be viewed by clicking the button below.