Events

Alerta De Seguridad para Temperature Monitoring System

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 3M Company || 3M Health Care.

¿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
    R1710-518
  • Número del evento
    2014DM-0011649
  • Fecha
    2017-10-31
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=65
  • 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 has confirmed that the detected temperature could be a little lower than the actual temperature of the patient, if the im- paired sensors are used as part of a system that is the only means of temperature monitoring, there is the possibility of performing inappropriate therapies, leading to possible adverse events on patients are presented.

Device

Temperature Monitoring System
  • Modelo / Serial
    Bair Hugger 36000 and SpotOn reference sensors,
  • Descripción del producto
    The SPOTON temperature control system is a direct thermometer that uses the zero-flow thermometry-heat technique to produce an accurate estimate of the temperature of deep tissue in a person. SPOTON is used to measure, monitor, and supply the body temperature trend of adult and pediatric patients.
  • Manufacturer
    3M Company || 3M Health Care

Manufacturer

3M Company || 3M Health Care
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    NIDFSINVIMA