Events

Notificaciones De Seguridad De Campo acerca de Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Abbott Laboratories.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-08-28
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Battery alert (bpa) is intended to alert the battery to malfunctioning in affected devices before the battery is discharged prematurely and before the device reaches eri voltage. battery information is automatically uploaded daily to merlin.Net ™, which analyzes all the data of the last 32 days on a daily basis, allowing you to detect any unusual trends in battery voltage. when a bpa is triggered, a notification will be sent to you via the merlin.Net ™ remote monitoring system and merlin ™ device during routine inspections. patients not monitored through the merlin.Net remote monitoring system may have their battery status and answer the question of whether the bpa triggered an alert determined only upon personal examination with a merlin ™ device.

Device

Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Qua...
  • Modelo / Serial
    CD1233-40 Fortify™ VR CD2233-40Q Fortify™ DR CD3251-40 Unify Quadra™ CD3361-40C Unify Assura™ CD1233-40Q CD2235-40 Fortify™ ST DR CD3251-40Q CD3361-40Q CD1235-40 Fortify™ ST VR CD2235-40Q CD3255-40 Unify Quadra MP™ CD3361- 40QC CD1235-40Q CD2259-40 Fortify Assura™ DR CD3255-40Q CD3367-40 Quadra Assura™ CD1259-40 Fortify Assura™ VR CD2259-40Q CD3261-40 Unify Assura™ CD3367-40C CD1259-40Q CD2299-40 HeartMinder™ ST DR CD3261-40Q CD3367-40Q CD1299-40 HeartMinder™ ST VR CD2299-40Q CD3267-40 Quadra Assura™ CD3367- 40QC CD1299-40Q CD2359-40 Fortify Assura™ DR CD3267-40Q CD3371-40 Quadra Assura MP™ CD1359-40 Fortify Assura™ VR CD2359-40C CD3271-40 Quadra Assura MP™ CD3371-40C CD1359-40C CD2359-40Q CD3271-40Q CD3371-40Q CD1359-40Q CD2359- 40QC CD3281-40 Excelis Quadra™ CD3371- 40QC CD1359-40QC CD2391-40C HeartMinder™ + DR CD3281-40Q CD3385-40C Quadra + Excelis™ CD1391-40C HeartMinder™ + VR CD2391- 40QC CD3297-40 Excelis™ CRT-D CD3385- 40QC CD1391-40QC CD3235-40 Unify™ CD3297-40Q CD3389-40C Excelis™ + CD2233-40 Fortify™ DR CD3235-40Q CD3361-40 Unify Assura™ CD3389- 40QC
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    AMPMDRS