Urgent Medical Device Correction.

The analysis of a customer complaint has identified an issue relating to the battery charge of the HAMILTON-C2/C3 batteries after a usage of two and a half years. After two and a half years, the battery fuel gauge may indicate a higher battery charge as to what is available. The technical failure 444001 ”low battery” high priority alarms are triggered, alerting the operator both acoustically and visually before entering ambient mode.

When batteries are depleted, the operator is alerted by high priority alarms and if the ventilator is not immediately connected to an AC power outlet, the ventilator will switch into ambient mode. The alarm is triggered in every case to alert medical staff.

Action required by device operators:

The operator or service personnel should make themselves familiar with the batteries’ date of installation and manufacturing date and react in time if the battery is more than two years in operation or maximum three years from the manufacturing date.

By filling out the form below, I confirm that I have received and noted this Medical Device Correction, stating that there is a potential issue with the reporting of battery life of the HAMILTON-C2/C3 ventilators. I will follow the instructions regarding the malfunction. 

The entire Medical Device Correction and list of affected devices can be viewed by clicking on the respective buttons below.