Important Safety Alerts

Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning its Philips V680 ventilators.

According to the manufacturer, the affected product may experience two potential issues with the navigation ring interface. It may i) become inoperative or operate intermittently and ii) the navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments. Both of these problems are typically associated with liquid ingress causing damage to the navigation ring. The probability of harm associated with these issues is unlikely.

The manufacturer has received no reports of death or serious injury associated with this navigation ring failures. However, in the worst-case scenario, if affected users accept an incorrect setting and leaves the patient on the ventilator without responding to the resulting alarms, the patient could sustain a serious injury, specifically hypercarbia, hypocarbia, barotrauma, or hypoxemia.

The manufacturer has advised affected users to take the following actions:

• When cleaning the affected product, do not allow cleaning agents to pool on the ventilator surfaces. This is especially important on the device interface.
• Check setting changes before and after accepting the changes.
• If the navigation ring becomes inoperative or operates intermittently during clinical use, use the touchscreen for all settings changes and navigation, and contact the manufacturer to schedule service following clinical use.
• If the navigation ring interferes with affected user's ability to adjust therapy settings via touchscreen, remove the ventilator from service and contact the manufacturer for repair.
• Review Chapter 1 and Chapter 10 of the V680 user manual.

According to the local supplier, the affected products are distributed in Hong Kong.

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

Posted on 11 January 2021