Events

Alerta De Seguridad para Patient Monitor MINDRAY

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 Shenzhen Mindray Bio-Medical Electronics Co.,Ltd.

¿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
    I1608-318
  • Número del evento
    2016EBC-0014959
  • Fecha
    2016-08-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=128
  • 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 it has detected the possibility that when using the equipment in continuous periods greater than 48 days, they may freeze the screen, causing the parameters and the dereference waveforms can not be renewed and the alarms can not be provoked, leading to to the possible occurrence of adverse events on patients.

Device

Patient Monitor MINDRAY
  • Modelo / Serial
    BENEVISION N22 and BENEVISION N19.
  • Descripción del producto
    The BENEVISION N22 and N19 patient monitors are designed to monitor, visualize, review, store, generate alarms and transfer various physiological parameters, including ECG (selectable between 3, 5, 6 and 12 leads, arrhythmia detection, ST segment analysis , QT / QTC monitoring and heart rate (HR)), respiration (RESP), temperature (TEMP), oxygen saturation by pulse oximetry (SpO2), pulse rate (PF), non-invasive blood pressure (NIBP), invasive blood pressure (PAI), cardiac output (CO), carbon dioxide (CO2), oxygen (O2), anesthetic gas (GA), impedance cardiography (ICG), bispectral index (IBE), respiratoryrespiratory (MR), continuous cardiac output (GCC) ), central venous oxygen saturation (SCVO2), electroencephalogram (EEG) and neuromuscular transmission (NMR). The monitor also provides an interpretation of the ECG of 12 deviations at rest.
  • Manufacturer
    Shenzhen Mindray Bio-Medical Electronics Co.,Ltd

Manufacturer

Shenzhen Mindray Bio-Medical Electronics Co.,Ltd