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Esprit Ventilator Model V1000 Recall
July 2, 2003 - The FDA Center for Devices and Radiological
Health posted a Class I recall notice for the Esprit Ventilator
Model V1000 by Respironics California, Inc., of Carlsbad,
California. Material used to construct three check-valves
in this ventilator predisposed the valves to premature failure.
There have been two patient injuries resulting in partial
or complete failure to permit ventilation.
According to FDA.gov, a Class I recall represents the highest
level of risk and is reserved for products that could likely
cause serious health problems or death.
The device is a computer controlled, electrically powered,
mechanical ventilator. It is intended to provide ventilatory
support for adult and pediatric patients suffering breathing
distress.
A material used to construct three check-valves in this ventilator
predisposed them to premature failure and their orientation
in the ventilator could also have caused a problem. There
have been two patient injuries resulting in partial or complete
failure to permit ventilation.
The FDA made this decisision due to a reasonable probability
that use of the product presents a high risk of serious adverse
health consequences, including death.
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