The U.S. Food and Drug Administration (FDA) posted a medical device safety alert concerning EnVe and ReVel Ventilators, manufactured by CareFusion.
The manufacturer has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and preventing charge to the ventilator battery.
For details, please refer to the FDA website
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=69020&w=10012014⟨=eng
According to the local supplier, the affected products were not distributed in Hong Kong.
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 3 October 2014