Covidien alerts U.K. regulators over possible ventilator battery failure

For the second time this year, Covidien ($COV) is warning the U.K. market about possible battery failures involving two brands of portable home use ventilators.

The Massachusetts device and medical products giant first issued safety alerts for several models of its Legendair single branch, Legendair double branch and Supportair ventilators (manufactured by Airox and supplied by Covidien) in April, according to the alert filed with the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA). But users didn't confirm with the company that they got the news and acted on it, the notice explains.

As MassDevice reports, the alert went out to patients in England, Northern Ireland, Scotland and Wales. Problems center around a capacitor on a printed circuit board in the products, though they still function on external battery power, the notice explains. Covidien wants affected patients to seek a replacement printed circuit board for the ventilator, whose failure led to the internal battery failure. Covidien and the regulators also warn that users of the affected products should watch their ventilators closely, and make sure they have a backup ventilator if traveling.

No word yet if the product has drawn any attention from U.S. regulators.

Separately, the FDA recently issued a safety alert for Covidien's Onyx liquid embolic system. The company said it is working to address regulators' concerns about the product, which blocks blood flow in abnormally-formed blood vessels in the brain before they're removed surgically. The FDA has also recently had its eye on ventilator problems of a different sort. Regulators took action against GE Healthcare for the company's Aestiva/5 7900 ventilator, slapping a Class I recall tag on the product because a flaw could lead to circulatory shock and death.

Covidien plans to report its 2012 third-quarter earnings on July 26.

- read the alert in detail
- check out MassDevice's take

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