The FDA yesterday announced a Class I recall – the most serious type of recall – on O-Two Medical Technologies’ o_two e700, e600 and e500 Automatic Transport Ventilators due to potential risk of fire. Use of these devices may cause serious injuries or death.
Intended for use on patients in cardiac arrest or respiratory distress who need assistance breathing, the O-Two Medical Technologies’ e700, e600 and e500 Automatic Transport Ventilators are emergency and transport ventilators designed for use before arriving at the hospital, in the hospital, between hospitals, and in transport settings.
FDA said the recall is due to an improperly inserted screw in the ventilator screen that could potentially wear through the electrical insulation and create a short circuit that could lead the device to catch fire and injure the patient. Fires in oxygen rich environments in a hospital or other healthcare facility pose an increased risk of serious injury or death to both patients and device users
Recalled products details:
· o_two e700, e600 and e500 Automatic Transport Ventilators
· Model Number: 01EVE700, 01EVE600 and 01EVE50
· Serial Numbers: e700: EV70001 to EV70658; e600: EV60001 to EV60126; e500: EV50001 to EV50148
· Distribution Dates: July 2013, to November 2018.
· Manufacturing Dates: July 2013, to January 2019.
· Devices Recalled in the U.S.: 469
O-Two Medical Technologies provided the following recommendations:
Customers are to stop using the device and immediately return any of the following units that have undergone Thin-Film-Transistor (TFT) screen replacement or have had service performance in the screen area. This includes units with serial numbers:
EV50090-2016, EV60003-2014, EV60049-2016, EV70091-2014, EV70172-2015, EV70173-2015, EV70181-2015, EV70335-2016, EV70340-2016, EV70418-2017, EV70426-2017, EV70435-2017, EV70473-2017, EV70531-2017
For all other customers, the firm instructed that they return their units for service inspection in accordance with the arrangements made by their local supplier for corrections to their ventilators.
Customers with questions may contact O-Two Medical Technologies, Inc. at 1-800-387-3405 Monday through Friday, 7:30 AM to 3:30 PM Eastern Standard Time.
