The FDA has issued a Class I recall, the most serious type of recall, for The Physio-Control Lifepak 15 Monitor/Defibrillator (LP15). Use of these devices may cause serious injuries or death.
- Distribution Dates: September 13, 2014, to July 4, 2016
- Manufacturing Dates: September 3, 2014 to June 30, 2016
- Devices Recalled in the U.S.: 139 nationwide
The LIFEPAK 15 Monitor/Defibrillator is used to deliver life-saving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the defibrillator to help the device analyze a patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The LIFEPAK 15 monitor displays the patient’s heart rhythm in waves so the health care provider can study the heart’s electrical activity.
Physio-Control is recalling the LIFEPAK Monitor/Defibrillator due to an electrical problem which may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. If the electrical shock is not delivered, the monitor will indicate “Abnormal Energy Delivery” on the display.
A delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.
Who May be Affected
- Health care providers and first responders using this monitor/defibrillator
- Patients who may need this defibrillation to restore normal heart rhythm
On January 12, 2017, Physio-Control sent an “Urgent Medical Device Correction” letter to all affected customers. The letter asked customers to:
- Review the safety notice and make sure appropriate staff is aware of the notice.
- Follow the instructions on the “Confirmation Sheet” for each serial number listed in the facility’s possession, and return the completed Confirmation Sheet to Physio-Control.
- Perform the “User Test” every day, as instructed in the LIFEPAK 15 Operating Instructions, page 10-4. If the device fails the “User Test”, as described in the notice, contact Physio-Control immediately to arrange for correction of the device.
- Continue to perform the User Test as outlined in the Daily Operator’s Checklist within the LIFEPAK 15 Operating Instructions.
Health care professionals and consumers with questions are instructed to contact Physio Control at 1-800-442-1142 with any questions related to this recall.