PHYSIO CONTROL ANNOUNCES URGENT MEDICAL DEVICE RECALL
LIFEPAK CR® Plus defibrillator / LIFEPAK EXPRESS® defibrillator
REDMOND, WA – On July 25, 2008, Physio-Control, Inc., a division of Medtronic, Inc., alerted distributors who sell LIFEPAK CR Plus and/or a LIFEPAK EXPRESS defibrillators manufactured between November 2006 and March 2008. These units have been identified as having a lead-free component that may be susceptible to failure and prevent the AED from powering on. The internal flex cable may lead to a short and prevent the unit for turning on, though the readiness indication states that the unit is fully operational. A defibrillator will not function if the unit cannot be turned on. In that notice, it is recommended that customers perform regular inspections (at least every 30 days) to ensure the unit properly turns on and the defibrillator is ready for use. There have been no confirmed cases of adverse events due to this failure and Physio-Control is only aware of three known and confirmed cases. The company’s analysis indicates that the potential for future failure is rare.
Due to the fact that Physio-Control AED units have been suspended from shipment since January, 2007 in the United States market, the majority of AED units affected are located outside of the United States – primarily in Japan. Physio-Control is now notifying customers of its decision to voluntarily recall all potentially affected LIFEPAK CR Plus/LIFEPAK EXPRESS defibrillators. “This field action is unrelated to suspended shipments of units and in many ways proves the improved quality control procedures implemented since the stop-ship began,” says Micah Bongberg, VP of Business Development for MasterCPR, a national Physio Control distributor. “Although the company’s analysis determined the likelihood of failure is still rare, the company is taking this step to eliminate the possibility of future failures because they believe it is in the best interest of their customers,” adds Bongberg.
Physio-Control takes patient safety first when considering a field action of this nature, scope, and magnitude. As soon as they received news of a potential problem, Physio-Control engineers analyzed the part in question (the internal flex cable), and made a proactive decision based on the best interests of their clients and public safety. Physio-Control is driven to exceed the expectations of their customers, and therefore has elected to recall and replace the units in question, though the chances of this adverse condition affecting end-users are remote. Physio-Control realizes that this recall may be seen as a burden to their clients, but their commitment to providing the highest quality customer service has led to the voluntary election and pursuit of this recall.
All affected AED units will be replaced at no charge to the client. In the interim, Physio-Control recommends that users concerned about their susceptibility to this problem take the following actions to ensure they have a fully functioning AED unit avaiable. If, after taking these actions, AED owners find that they are indeed in the remote scope of affected users, they should call either MasterCPR or Physio-Control to coordinate an immediate, free-of-charge AED replacement. All others will be contacted by their distributors and/or Physio-Control Customer Service within 60 days to arrange replacement of any potentially affected AED units.
Recommendations to test potentially affected AED units (monthly):
Step 1: Check readiness indicator.
Step 2: Conduct a power-on self test by pressing the “On” button. Ensure that the AED and voice prompts are activated. Once complete, turn off the
unit by pressing the “On/Off” button.
Step 3: If the voice prompts were activated, keep the AED in use and perform regular monthly self tests, including the Power-on self test mentioned above.
Step 4: If the AED’s voice prompts are not activated during the self test, immediately call Physio-Control Technical support (800.442.1142) or MasterCPR
Customer Service (866.364.7940).
- Inspect your defibrillator at least monthly to ensure battery is functional.
- If “OK” is visible on the readiness display, conduct a self test by turning the AED on and waiting for voice prompts.
- If any other indicator is present, please immediately contact your authorized Physio-Control service representative at 800.442.1142 or MasterCPR Customer Service at 866.364.7940
If you have additional questions about whether your defibrillator is included in this recall, you can visit Physio-Control’s website at http://www.physio-control.com/ or contact MasterCPR at 866.364.7940.
For more than 50 years Physio-Control, Inc.(http://www.physio-control.com/), maker of renowned LIFEPAK® defibrillators, has been developing technologies and designing devices that are legendary among first response professionals, clinical care providers and citizens everywhere. With over 650,000 LIFEPAK® external defibrillators in operation worldwide, Physio-Control is the global leader in external defibrillation. Physio-Control currently holds more than 70 percent of the domestic emergency medical services (out-of-hospital) market and nearly 50 percent of the domestic in-hospital market.
MasterCPR (http://www.MasterCPR.com) is a leading provider of health, safety, emergency preparedness and emergency response services in the nation. They assist businesses and organizations with health training programs from preventative solutions like healthy eating habits and exercise programs to training programs for CPR, AED use and first aid safety.