BEUDAMED
    319 results · 64ms · Sources: EU EUDAMED, US FDA

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    LIFEVEST WCD 4000 SYS

    FDA Adverse Event
    Death ·ZOLL MANUFACTURING CORPORATION·Product code MVK·October 1, 2014

    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    FDA Enforcement
    Class II ·Terminated·Zoll Manufacturing Corp.·January 24, 2018

    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    FDA Recall
    Terminated ·Zoll Manufacturing Corp.·Product code MVK·September 12, 2017

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 10, 2013

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 10, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·June 23, 2015

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORP·Product code MVK·December 2, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Death ·ZOLL MANUFACTURING CORP·Product code MVK·November 14, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORP·Product code MVK·December 2, 2014

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Death ·ZOLL MANUFACTURING CORP·Product code MVK·November 14, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORP·Product code MVK·November 12, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORP·Product code MVK·November 12, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORP·Product code MVK·December 31, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Death ·ZOLL MANUFACTURING CORP·Product code MVK·November 14, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORP·Product code MVK·December 2, 2014

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Death ·ZOLL MANUFACTURING CORP·Product code MVK·November 14, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORP·Product code MVK·November 12, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORP·Product code MVK·November 12, 2014

    LIFEVEST WCD 400 SYSTEM

    FDA Adverse Event
    Death ·ZOLL MANUFACTURING CORP·Product code MVK·November 14, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORP·Product code MVK·November 12, 2014