Video: Defibrillator coming under scrutiny

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SEATTLE – A medical device that is made in Western Washington and is supposed to save people's lives may not work.

A certain kind of defibrillator is coming under the scrutiny of the FDA once again.

When someone suffers a heart attack, seconds count. But now the FDA says it once again found significant problems at Physio Control's Redmond plant, again raising questions about its Lifepak defibrillators.

According to court records, the FDA is still not satisfied with Physio Control's production and quality assurance program, and expressed doubt the company is fully investigating reports of defective units that are used by hospitals and paramedics, and can be found in public buildings, airports, and health clubs.

Problems have plagued Physio Control since the 1990s when bad batteries led to a major recall of the devices used to restart a heart with an electric shock.

Last year, following continued government criticism, the company suspended domestic shipments and cut 300 jobs.

Wednesday, the FDA is expected to outline its latest agreement with Physio Control aimed at resuming normal sales and production, including appointing an independent expert to oversee quality control.

In a statement, Physio Control says it has made "significant investments and improvements to our quality systems" and it hopes to start shipping Lifepaks sometime this summer.

At this point no one in the emergency services is calling the FDA's concern a serious threat to public health and safety.