Medtronic Unit to Resume Sales of Lifepak Defibrillators

We recently wrote that Physio-Control, Inc., a division of Medtronic, Inc., recalled its <"">LifePak CR Plus Automated External Defibrillators (AED). The Food & Drug Administration (FDA) deemed that recall a Class I, the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. Physio-control makes external defibrillators.

Just prior, Medronic issued a recall of some of its portable Lifepak Automated External Heart Defibrillators because the button that activates the device is inaccessible, also an FDA-deemed Class I recall.

Now, the Star Tribune is reporting that Physio-Control Inc. just announced it has received approval to resume shipments of the medical devices nearly two years after federal regulators found quality problems at its plant in Redmond, Washington.

In May 2008, Physio-Control subsidiary signed a consent decree with the agency in which it agreed to address quality system problems. The FDA claimed that Physio-Control did not correct manufacturing problems, nor did it properly look into complaints related to its external defibrillator model typically found in hospitals nationwide, said the Star Tribune.

On Friday, said the Star Tribune, Medtronic—Physio-Control’s parent company—said it was in receipt of an FDA notification indicating that all mandates were met.

Emergency or medical personnel use this medical device, as do others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient’s heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.

The agreement was reached in 2008, on the consent decree with the FDA over quality system improvements for its external defibrillators. The agreement addressed concerns raised by the FDA during inspections and outlined actions Medtronic’s Physio-Control subsidiary must take to resume unrestricted distribution of the portable electronic devices.

AEDs are becoming more and more available in office buildings, schools, and other public venues for use by bystanders to help a person suffering from sudden cardiac arrest. Physio-Control stopped U.S. shipments in January 2007 due to quality problems. Medtronic said shipments to meet critical customer requirements and certain specified public health needs will continue; however, in September that year, Medtronic announced plans to eliminate about 200 jobs in the Physio-Control unit.

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