BEUDAMED
    12 results · 101ms · Sources: EU EUDAMED, US FDA

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    PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.

    FDA Recall
    Open, Classified ·Precision Valve & Automation, Inc·Product code BTL·June 26, 2020

    PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.

    FDA Enforcement
    Class II ·Ongoing·Precision Valve & Automation,Inc·August 26, 2020

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·June 27, 2008

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 7, 2018

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·November 24, 2017

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·July 19, 2018

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Other ·BECMAN COULTER, INC.·Product code MMI·June 10, 2008

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·April 8, 2026

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·April 4, 2018

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·February 28, 2018

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·January 2, 2018

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices