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Wearable External Defibrillator Warning; Failure to Provide Shock


On January 17, 2018, the FDA provided information and recommendations regarding the Zoll LifeVest 4000 due to concerns that the device may fail to deliver treatment to the patient if the device is not replaced soon after displaying the message, “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102.” Failure to contact Zoll and immediately replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death because the device may fail to deliver therapy appropriately when needed.

 

The Zoll LifeVest 4000 is a wearable defibrillator used to treat life-threatening abnormal heartbeats (arrhythmias) in adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator. The LifeVest continuously monitors the patient’s heart and, if a fast, life-threatening heart rhythm is detected, the device delivers a treatment (i.e., a shock) to restore the patient to a normal heart rhythm.

 

During normal operation, the LifeVest monitors the patient’s heart, delivering a “treatment shock” as needed to restore the patient’s heartbeat to a normal rhythm. However, in certain cases the LifeVest 4000 may not be able to deliver a life-saving treatment shock to a patient due to a fault that prevents the device from charging its high-energy capacitors. During normal operation, this fault prompts the LifeVest to display “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102” on the device screen. The “Message Code 102” alert does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately.

 

To date, the FDA is aware of one patient death due to the LifeVest’s failure to deliver treatment as expected after “Message Code 102” was displayed. According to Zoll, as of November 14, 2017, there were a total of 33,670 devices distributed, with 24,975 devices distributed in the U.S. Approximately 0.1 percent of the total devices distributed have displayed “Message Code 102,” which requires immediate replacement of the device.

 

The FDA recommended that health care providers should train patients in the prescribed use of the Zoll LifeVest 4000 including how to identify the “Call for service, Message Code 102” alert. “Message Code 102” may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing. The alert will read “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” and will allow the patient to tap “OK” to return to normal operation.

 

The FDA recommended that health care providers should inform patients to respond to the “Call for service, Message Code 102” alert on the LifeVest 4000 screen by contacting Zoll immediately. “Message Code 102” may mean that the LifeVest 4000 has a severe service problem and cannot be used because the device may not appropriately deliver life-saving treatment if needed. Zoll will replace the patient’s device within 24 hours if the device displays “Message Code 102.”

 

The FDA recommended that health care providers should reinforce initial LifeVest 4000 training, explaining that the device can display messages on the screen and play audio alerts that require the patient to take action. If “Message Code 102” does not appear on the device screen, the patient should continue to use the LifeVest 4000 as prescribed, and read the display for gong alerts and follow the instructions on the screen.

 

See the FDA Safety Alert

 

See the FDA Safety Communication

 

See also Medical Law Perspectives Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease

 

See also Medical Law Perspectives Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks

 

See also Medical Law Perspectives Report: Diagnosis and Treatment of Heart Attacks: Liability Issues

 

 

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