The U.S. Food and Drug Administration (FDA) has announced the recall of Newport Medical Instruments’ HT70 and HT70 Plus Ventilators after reports of units going into internal backup battery sooner than expected, while the ventilator is being operated on Power Pac battery.
The HT70 and HT70 Plus ventilators provide continuous or intermittent mechanical breathing support for individuals who cannot breathe on their own. Two different dangerous situations prompted the ventilator recall. In the first, the screen on the Newport Medical Instrument’s HT70 Ventilator or HT70 Plus Ventilator may indicate that the Power Pac battery is fully charged when it is not. In the second situation, the unit may switch to backup battery power as soon as it is removed from AC power.
This is a Class 1 recall, the FDA’s most serious category, reserved for situations in which there is a “reasonable probability” that use of the product could result in serious adverse health consequences or death.
The serial number range of the recalled ventilators is 2096134110001 to 2292048120050, Rev. C through Rev. F. The ventilators were manufactured between November 1, 2009, and March 5, 2013, and distributed from October 1, 2011, to January 31, 2013.
Newport Medical Instruments sent an Urgent Medical Device Recall letter to affected customers, notifying them of the problem and the action to take. Healthcare facilities, distributors, and ventilator users were advised to check the serial numbers of their Newport HT70 and HT70 Plus ventilators and, if the number falls within the range listed above, they should contact Newport Medical Instrument’s Technical Support Department at 1.800.451.3111 to request replacement batteries, which will be provided at no charge.
The company advises customers using the affected ventilators to ensure that an alternate source of power is available nearby until this issue is resolved.
To report problems or adverse events to the FDA through the MedWatch Safety Information and Adverse Event Reporting Program, go to www.fda.gov/MedWatch/report.htm.