Thursday, September 19, 2019

Thursday, September 19, 2019

U.S. FOOD AND DRUG ADMINISTRATION: o_two e700 Automatic Transport Ventilator


U.S. Food and Drug Administration recently issued the following announcement. 

Date Initiated by Firm: February 12, 2019

Create Date: April 04, 2019

Recall Status: Open, Classified

Recall Number: Z-0978-2019

Recall Event ID: 82178

510(K)Number: K141595  

Product Classification: Ventilator, emergency, powered (resuscitator) - Product Code BTL

Product: e700 Automatic Transport Ventilator, Model Number 01EVE700

Code Information: EV70001 to EV70658

Recalling Firm/Manufacturer: O-Two Medical Technologies, Inc.

                                                   45A Armthorpe Road

                                                   Brampton Canada L6T 5M4

                                                   Ontario

For Additional Information Contact: Brenda Chard

                                                              905-792-6896

Manufacturer Reason

There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit. 

FDA Determined Cause: Process control

Action: Urgent Medical Device Correction notification letters dated 2/7/19 were sent to customers.

An additional letter was sent to customers on 3/4/19.

Quantity in Commerce: 632

Distribution: The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.

Total Product Life Cycle: TPLC Device Report

Original source can be found here.

Organizations in this Story

U.S. Food and Drug Administration

More News

FDA Reporter