Medical device manufacturer, Philips, has issued a medical device safety alert concerning its V60 Ventilators.
According to the manufacturer, V60 ventilators may experience two potential issues with the navigation ring interface. Both of these problems are typically associated with liquid ingress causing damage to the navigation ring.
- The navigation ring may become inoperative or operate intermittently.
- The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
The manufacturer is advising the affected users to take following actions:
- When cleaning V60 ventilators, 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, affected users should use the touchscreen for all settings changes and navigation, and contact Philips representative to schedule service following clinical use.
- If the navigation ring interferes with affected users' ability to adjust therapy settings via touchscreen, they should remove the ventilator from service and contact Philips representative for repair.
Affected users should review the following sections of the V60 user manual:
- Chapter 10: Care and maintenance. To prevent possible damage to the ventilator when cleaning, use only those cleaning and disinfecting agents listed, and do not drip or spray any liquids directly onto any ventilator surface.
- Chapter 1: Warnings, cautions, and notes. During clinical use of the ventilator, monitor patients for changes in respiratory status with each ventilator setting adjustment. Use an external oxygen monitor to verify oxygen concentration, and have an alternative means of ventilation available whenever a ventilator is in use.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 November 2020