Events

Safety Alert for Patient Monitor MINDRAY

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Shenzhen Mindray Bio-Medical Electronics Co.,Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1608-318
  • Event Number
    2016EBC-0014959
  • Date
    2016-08-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=128
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    BENEVISION N22 and BENEVISION N19.
  • Product Description
    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