In an emergency, New Jersey residents who suffer from a cardiac arrest might require emergency responders to use a defibrillator to restart their hearts. This is done through the administration of an electrical shock to the patient. On Feb. 10, the U.S. Food and Drug Administration announced a Class I recall for the LIFEPAK 15 Monitor/Defibrillator (LP15). The recall of these defective products affects cardiac patients and the medical personnel who use them.
The FDA lists this as a Class I recall due to the potential for serious injury or death. When a New Jersey resident is believed to be in cardiac arrest, the machine's electrodes are attached to the patient to determine heart rhythm and deliver an electric shock if needed. Unfortunately, an electrical problem with these devices might prevent the shock from being delivered, which could lead to death, serious injury and permanent damage to the patient's organs, including the brain.
When medical personnel attempt to deliver a shock and the machine does not respond, the display will read that an "Abnormal Energy Delivery" took place. The company that manufactures the device, Physio-Control, was aware of a problem back in January when it sent "Urgent Medical Device Correction" correspondence to its customers. The letters urged users to perform a daily test to ensure the device would operate appropriately. Now, the devices are being recalled altogether.
Considering the importance of a defibrillator, many people might agree that these dangerous and defective products should have been recalled much sooner. Any patient who suffers any adverse effect or the surviving family of anyone who dies as a result of this product might benefit from seeking the advice of an attorney. The long-term ramifications to the patient and his or her family could lead to a significant amount of financial losses due to medical expenses, lost income and other damages, including funeral and burial costs if death occurred.
Source: fda.gov, "Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery", Feb. 10, 2017