A Class I recall has been issued for more than 50,000 LIFEPAK defibrillators, following dozens of reports that suggest certain devices may fail to deliver lifesaving electrical shocks to individuals suffering cardiac arrest.
The FDA announced a LIFEPAK 1000 defibrillator recall on March 8, indicating that the action poses a risk of serious injury or death. At least 34 reports have been received indicating that the defibrillator unexpectedly shut down during emergency shock treatments, due to insufficient electrical contacts on the batteries.
The LIFEPAK 1000 defibrillators are designed to deliver lifesaving electrical shocks to people with sudden cardiac arrest, which is a medical condition in which the heart suddenly stops beating. The defibrillators have electrodes that are attached to a patient, which analyze the patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when necessary. The devices are used in the medical field by trained professionals and commonly by medical emergency first responders.
On January 13, 2017, Physio-Control released an “Urgent Medical Device Correction” letter to all affected customers, warning medical professionals of the potential power loss the devices may experience. The announcement this week categorized this action as a Class I recall, which is the most serious type.
According to the urgent medical notice, after learning about the reports of problems with LIFEPAK 1000 defibrillators, the manufacturing company, Physio-Control, immediately conducted a field investigation and found the “intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts.”
After performing their field investigation, the company warned the FDA that if the devices are exposed to excessive vibration, or have had a battery installed that has not been replaced or removed from the device over a long period of time, the unexpected power failures are likely to occur, placing patients who suffer cardiac arrest in potentially fatal situations.
In the event a patient who has entered into cardiac arrest is delayed or unable to receive the electrical shock to restore their heart beat rhythm due to unexpected power failures, the patient could suffer serious injury such as permanent organ damage, brain injury or death.
The recall affects an estimated 50,046 LIFEPAK 1000 defibrillators marked with Part Number 320371500XX. More than 133,330 serial numbers are included in the worldwide recall. Customers may search for their defibrillators serial number by visiting http://www.physio-control.com/Search_Affected_Devices.aspx.
The recalled defibrillators were manufactured by Physio-Control of Redmond, Washington, whose parent company is Stryker Corporation. The defibrillators were manufactured from June 30, 2006 to December 20, 2016 and were distributed to medical facilities and medical professionals from June 30, 2006 to December 23, 2016.
Customers are being asked to follow the instructions sent by Physio-Control on the urgent medical notice which instruct users to immediately remove the battery and ensure the terminal connectors are clear and implement a weekly battery removal and reinstallation process to prevent oxidation buildups. Customers who have followed these protocols and still experience unexpected power failures are being asked to replace the battery with a spare and call Physio-Control immediately at 1-866-231-1220 to arrange for servicing the device.