Newport Medical Instruments, Inc. has recalled two of its ventilators in a move deemed a Class I recall by the U.S. Food and Drug Administration (FDA). The recall involves models HT70 and HT70 Plus ventilators, which go into internal backup battery sooner than expected, the FDA announced.
An FDA Class I designation means that this involves a situation in which there is a reasonable probability that the use of, or exposure to, the violative product (recalled product) will cause serious adverse health consequences or death.
In this case, Newport Medical Instruments implemented the recall following customer reports of the HT70 and HT70 Plus ventilators alarming and going into internal backup battery sooner than expected, while the ventilator was being operated on Power Pac battery.
The serial number range involved is 2096134110001 to 2292048120050, Rev. C through Rev. F The recalled ventilators were manufactured from November 1, 2009 to March 5, 2013 and distributed from October 1, 2011 to January 31, 2013.
The conditions that prompted the recall have reported in two types of situations:
- The ventilator screen may indicate that the Power Pac battery is fully charged when it is not
- Tnit may switch to backup battery power as soon as it is removed from AC power.
The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical “ventilatory” support for the care of individuals who require mechanical ventilation. Use of these ventilators on battery power may cause serious adverse health consequences, including death.
Newport Medical Instruments sent an Urgent Medical Device Recall letter by FedEx to all of its affected customers on April 4, 2013. The letter described the product, the problem, and the action to be taken by the customer.
Those with Power Pac batteries for the Newport Medical Instrument’s HT70 and HT70 Plus ventilators, including distributors, health care providers, and home users, must immediately check the serial numbers of the Power Pac batteries associated with their Newport HT70 and HT70 Plus ventilators. Customers whose Power Pac serial numbers fall within the recalled range should immediately contact Newport Medical Instrument’s Technical Support Department to request replacement batteries, which will be provided at no charge. The Technical Support Department may be reached toll-free, at 1.800.451.3111, extension 500. Customers were also instructed to report any issues with Newport Medical Instrument’s HT70 and HT70 Plus ventilators or Power Pac batteries to the Technical Support group.
Customers using the recalled HT70 or HT70 Plus ventilators should ensure that an alternate source of power is available until the issue is resolved.