Events

Alerta De Seguridad para unkown device

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Hill Rom Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1409-367
  • Número del evento
    2013DM -0010757
  • Fecha
    2014-09-08
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=196
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer issues certain recommendations to avoid the deterioration of the coupling systems of the foot section of the device produced by subjecting them to constant knocks and falls, leading to possible possible adverse events on patients or users.

Device

unkown device
  • Modelo / Serial
    AFFINITY models P3700B, P3700C, P3700D and P3700E, manufactured between October 2006 and June 2014.
  • Descripción del producto
    AFFINITY ™ FOUR obstetric beds are intended to be used as delivery cares for pregnant women with LDR (dilatation, delivery and recovery) or LDRP (dilation, delivery, recovery and postpartum). The hospital systems VERSACA RE ™ and TOTA LCA RE ™ s systems offer patient support perfectly adapted to hospital environments. Care units and intensive surveillance, medical-surgical care, post-anesthesia care unit and deurgery rooms, among others, can be used. The P ROGRESSA ™ bed is designed for the prevention or treatment of pulmonary complications or other associated complications with immobility; for the treatment or prevention of pressure ulcers; or for any other purpose where medical benefits can be obtained from continuous lateral rotation therapy or dermal / percussion therapy.
  • Manufacturer
    Hill Rom Inc

Manufacturer

Hill Rom Inc