Medtronic Works to Fix Defibrillators on Battery Problem

Physio-Control subsidiary said Friday it recently launched a field correction effort to fix certain devices used to shock patients in cardiac arrest because it found a potential battery-power problem, and that one patient may have died as a result.

The Food and Drug Administration said nearly 43,000 Lifepak 20 and Lifepak 20e defibrillator/monitors are at issue worldwide and assigned a “Class 1″ recall status to Phsyio-Control’s field action, which is the agency’s most significant recall level. The company isn’t pulling machines from the field, but is urging frequent testing as it works to fix them.

The company said the odds of a battery problem are slim. It also said hospital workers normally plug the external defibrillators into a wall socket, which ensures they’ll have power and run on batteries less often. The Medtronic unit is notifying all U.S. and global customers by certified mail and said it plans to update all affected power supplies at no charge.

“While there have been reports of failures during patient use, over the eight-year product life, there has been one unconfirmed adverse patient event,” Physio-Control said in a release.(toshiba stellite laptop battery)

Brian Webster, Physio-Control’s president, said there was one case in Australia four years ago where a patient reportedly died as a company defibrillator malfunctioned. But the company was unable to recover the device to confirm the problem and doesn’t know specifics about the situation, such as why it wasn’t plugged in.

The products in question are different from implantable defibrillators, which sit in patients’ chests like pacemakers and guard against potentially fatal rhythm disturbances. Instead, these are external devices for hospital-based first responders to use to shock hearts of patients in cardiac arrest.(dell replacement battery)

Physio-Control recommended that customers keep the units in service and continue testing devices frequently and regularly. The products in question were made before Jan. 9, 2009, Physio-Control said.

The company in April announced a field action to fix a different model—Lifepak 15 defibrillator/monitors used in ambulances—because of a potential electrical short. There were no adverse patient events, Physio-Control said at the time.

Webster said these field actions aren’t an example of problems at Physio-Control, which has long been under the FDA’s thumb for quality issues, but rather examples that a retuned company quality system is correctly identifying and fixing things. The latest issue involves a product designed eight or nine years ago, he noted.(ibm thinkpad battery)

“Clearly these are signs of a healthy quality system,” he said.

Physio-Control in February said it successfully met FDA requirements that allowed it to resume unrestricted global defibrillator shipments following a long hiatus pegged to quality issues. A consent decree agreement between the agency and company outlining needed improvements, reached in 2008, remains in place.

Medtronic had said in late 2006 that it planned to spin off Physio-Control into a publicly traded, independent company, but the regulatory issues caused a long delay. The strategic plan remains in place, Medtronic Chief Executive William A. Hawkins said in a February interview, but first the subsidiary needs to show it’s back on track.

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