Events

Alerta De Seguridad para Multiparameter Monitoring Equipment Intellivue

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 Witt Biomedical Corporation || Philips Medical Systems || Invivo Corporation || Philips Medizin Systeme Boeblingen Gmbh || Sanmina-Sci Systems Singapore Pte Ltd || Philips Goldway (Shenzhen) Industrial 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
    I1705-164
  • Número del evento
    2008EBC-0002562
  • Fecha
    2017-05-12
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=89
  • 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 reports that a small number of tnm patient cables may have an insulation defect located in the protection of the acceleration sensor housing, this defect in the manufacture may cause localized heat due to the development of an unforeseen current flow between the sensor housing and the acceleration coupled to the thumb of the patient and the delelectrode connection of tnm stimulation attached to the wrist of the same patient, which could lead to adverse events occurring on the patient.

Device

Multiparameter Monitoring Equipment Intellivue

Manufacturer

Witt Biomedical Corporation || Philips Medical Systems || Invivo Corporation || Philips Medizin S...
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NIDFSINVIMA