Zoll Lifevest 4000 Manual Average ratng: 5,0/10 3220votes
Welcome to ZOLL LifeVest The LifeVest wearable defibrillator is worn by patients at risk for sudden cardiac arrest (SCA), providing protection during their changing condition and while permanent SCA risk has not been established. The LifeVest allows a patient’s physician time to assess their long-term arrhythmic risk and make appropriate plans. The LifeVest is lightweight and easy to wear, allowing patients to return to their common activities of daily living, while having the peace of mind that they are protected from SCA. The LifeVest continuously monitors the patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm. The LifeVest is used for a wide range of patient conditions or situations, including following a heart attack, before or after bypass surgery or stent placement, as well as for those with cardiomyopathy or congestive heart failure that places them at particular risk. The LifeVest is covered by most health plans in the United States, including commercial, state, and federal plans.
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January 22, 2018 — The U.S. Food and Drug Administration (FDA) announced last week it is providing 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 '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 of the patient because the device may fail to deliver therapy appropriately when needed. Ideally, the LifeVest, delivering a 'treatment shock' as needed to restore the patient's heartbeat to a normal rhythm. However, FDA is aware that 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, 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 Nov. 14, 2017, there were a total of 33,670 devices distributed, with 24,975 devices distributed in the U.S.
The LifeVest wearable cardioverter defibrillator is a treatment option for sudden cardiac arrest that offers patients advanced protection and monitoring as well as. Welcome to ZOLL LifeVest. The LifeVest wearable defibrillator is worn by patients at risk for sudden cardiac arrest. Medical vest a life-saver for cardiac patients.
About 0.1 percent of the total devices distributed have displayed Message Code 102, which should only be remedied by immediate replacement of the device. The FDA will continue to work with Zoll to monitor LifeVest 4000 devices for any adverse events related to Message Code 102 or a failure to deliver treatment. Kamila Shamsie - Broken Verses.epub. The agency will also continue to work with Zoll to identify a permanent solution to the Message Code 102 issue, and will keep the public informed as new information becomes available.
The Zoll LifeVest 4000 is a used to treat life-threatening in adults and children who are at risk for 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. Frutiger Lt Font. e. A shock) to restore the patient to a normal heart rhythm. The FDA’s recommended actions for healthcare providers include: • Train patients prescribed use of the Zoll LifeVest 4000 on 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.