Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has issued a medical device safety alert concerning Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) ventilator unit, manufactured by Hamilton Medical AG.

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. 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.

According to the manufacturer, 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.

The affected users are instructed to take the following actions:-

• The operator should make themselves familiar with the batteries' manufacturing date and react in time if battery is more than two years old. Any battery with a manufacturing date to two years prior to the current date should be replaced.
• If the battery is less than two years old, return battery to slot, pushing until clip clicks into place, locking in the battery. Use a screwdriver to lock metal clip back into place over battery. Close battery door.

For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notice-29-august-to-1-september-2017

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 5 September 2017