The Zoll LifeVest was approved by the FDA in 2001. The woman’s son filed a complaint with a Florida state court, but Zoll moved the case to federal court where it was later dismissed. The woman lost consciousness and died several days later. The device made an audible alarm, but did not shock the woman. In 2013, a Florida woman died after her Zoll LifeVest failed to function properly during a defibrillation event. Instead, the vest routinely sounded warning alerts that terrified the entire family, burned the victim, and caused her pacemaker surgery to be delayed. The LifeVest was meant to protect her from heart failure by delivering shocks if she went into sudden cardiac arrest. She was wearing the vest while recovering from emergency heart surgery. In 2015, an 11-year-old girl was put in danger by her defective Zoll LifeVest. There have been numerous reports of false error messages that alert patients of a service problem, creating panic because patients expect their defibrillator to go off, but it fails to activate. If a problem occurs during normal operations, the monitor prompts the LifeVest to display a “Call for Service” message code on the device screen. According to the FDA alert, the device displays error messages and fails to charge properly for defibrillation. The wearable defibrillator vest is attached to a heart monitor that tracks a patient’s heart rhythms. The Federal Drug Administration (FDA) has issued a safety alert for the Zoll LifeVest after patient deaths occurred. Defective Defibrillator Vest Puts Patients at Risk Recent deaths have been linked to the Zoll LifeVest, a defibrillator vest that’s attached to an external heart monitor worn by patients in danger of heart failure.
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