Newport Ventilator Power Pac Batteries [US]


US/Silver Spring: Covidien recalls some Power Pac Batteries for Newport HT70 and HT70 Plus Ventilators due to operational failure, serious adverse health hazards. FDA: http://ht.ly/kvmlw

Direct link: http://www.fda.gov/Safety/Recalls/ucm348638.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports this recall was in response to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery. These conditions have been reported in two types of situations. In the first situation, the screen on the Newport HT70 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 the backup battery as soon as it is removed from AC power.

In both situations, according to the FDA, the ventilator’s alarm sounds and the ventilator will continue to function on the internal backup battery for at least 30 minutes. There is a reasonable likelihood of serious adverse health consequences if these issues occur when the user is away from AC power (including during transport) and an alternate source of power cannot be made available before the charge on the internal battery is depleted.

According the the FDA, the following Power Pac Batteries are subject to this recall:

  • Power Pac Batteries with serial numbers between 2096134110001 and 2292048120050

Recalls Direct RIN: 2013-1910
E. & O. E.

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