Defibrillator's are often thought of as a back up battery for patients, when cardiac issues arise. But what happens when the back up is in danger of giving out?
Physio-Control (Redmond, Washington) a subsidiary of medtech giant, Medtronic (Minneapolis, Minnesota) has developed the LifePak 20e defibrillator/monitor that displays the real-time status of available battery capacity and a fuel gauge so clinicians can monitor remaining use time more closely.
Despite coming under heavy fire for its defibrillator devices, the company said it soon plans to market the device.
"We are very pleased to have received 510(k) clearance from the FDA on the LifePak 20e defibrillator/monitor. Physio-Control has a long history of providing products for the hospital marketplace and the 20e will fit well into the line of reliable, quality products customers have come to expect from us," said Brian Webster, president of Physio-Control. "It is an exciting time for our company as we continue to provide our customers with new generations of LifePak products."
The device was approved to be marketed in the U.S. according to the company. The device is actually an enhancement to the LifePak 20, which has been widely in use since 2002. It is powered off more powerful Lithium-ion battery and is said to double the ECG monitoring time.
The device also was developed to be easily transported, helping hospitals meet the Joint Commission for Accreditation of Healthcare Organizations (JCAHO; Oakbrook Terrace, Illinois) standard for having resuscitation services readily available in all facility areas.
The company has been in the news lately and involved in a recent class I recall of 249 units of its LifePak CR Plus automated external defibrillators (AEDs) (Medical Device Daily, Sept. 15, 2008). The company initiated the recall because the units were loaded with software written for its semi-automated AEDs.
According to a Sept. 11 statement, the company already has completed the recall of the affected units, which when activated would display a prompt to "press the shock button to deliver therapy." Physio-Control indicated that the shock button is covered on the automated units and as a consequence, "it is possible that therapy could be delayed or not delivered at all, possibly resulting in death."
As of September 2 the company has notified all affected customers and shipped replacement devices at no charge. During the brief interval while customers awaited receipt of replacement devices, Physio-Control recommended that customers with the identified, affected defibrillators either remove the affected AED(s) from service or remove and discard the shock button cover (instructions provided).
And in May, the company signed a consent degree with the FDA that would prohibit the manufacture, distribution and export of specified AEDs at or from Physio-Controls facility in Redmond until the devices and facilities have been shown to be in compliance with the FDA's current Good Manufacturing Practice requirements, as set forth in the Quality System regulation for devices (MDD, May 2, 2008).
Physio-Control said although its currently under a consent decree with the FDA, which restricts the amount of products that can be delivered to customers until certain improvements in the company's quality system have been completed, it is permitted to manufacture and ship a limited selection of product under certain conditions to meet the critical needs of emergency response customers.
Despite the FDA consent decree Medtronic booked $94 million in revenue for Physio Control, during the company's fiscal first quarter.
For nearly two years Medtronic has delayed the spin off of Physio-Control (MDD, December 5, 2006) a company it acquired for $538 million in 1998.