Newport HT70 Ventilator…

Date posted by the FDA

June 2, 2011

Status

Terminated

Filed by

Newport Medical Instruments Inc

Product

Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport HT70 ventilator is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 Ibs). The Newport HT70 ventilator is suitable for use in hospital, subacute, emergency room, and home care environments as well as for transport and emergency response applications.

Reason

The recall was initiated because Newport Medical has confirmed a limited number of power cords recently received from their supplier, Glob-Tek, have a slightly oversized plug connector which prevents the cord from locking into place. These cords are fully functional as supplied. However, the cord can be easily disconnected. If the cord is disconnected, the HT70 will alert the user with a power di

Distribution pattern

Worldwide Distribution--USA (nationwide) including the states of MA, PA, OH, IA and Puerto Rico and the countries of Colombia, UAE, Hong Kong, Hungary, India, Japan, Nepal, China, Philippines, Singapore and South Africa.

Quantity

22 units total

Codes and lots

Serial Numbers: N10HT700810209 - N10HT700810218, N10HT700910219-N10HT700910225

Recall started

Sept. 20, 2010

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Other

What the company told customers

Newport Medical sent an PRODUCT NOTICE LETTER, dated September 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to discard the original cord and only use the replacement cord to avoid unintentional disconnection of the power cord. Each affected Customer was sent a replacement cord. Customers with any questions regarding the Product Notice were instructed to contact the Technical Support Department at (800) 451-3111.

Recall number

Z-2406-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2406-2011. The agency record governs; check it and the company before acting.