Physio-Control wins FDA approval for Lifepak 20e defibrillator/monitor

The Lifepak 20e defibrillator/monitor offers all the capabilities of the Lifepak 20 device, along with a lithium-ion battery that doubles ECG monitoring time and the run time of other parameters such as noninvasive pacing and pulse oximetry, a noninvasive way to monitor the oxygenation of a patient’s hemoglobin, the company said.

Additionally, a new on-screen ‘fuel gauge’ displays the real-time status of available battery capacity so clinicians can monitor remaining use time.

Physio-Control is 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. However, the company is permitted to manufacture and ship a limited selection of product under certain conditions to meet the critical needs of emergency response customers.

Brian Webster, president of Physio-Control, said: “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.”