Events

Safety Alert for Multiparameter Monitoring Equipment Intellivue

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Witt Biomedical Corporation || Philips Medical Systems || Invivo Corporation || Philips Medizin Systeme Boeblingen Gmbh || Sanmina-Sci Systems Singapore Pte Ltd || Philips Goldway (Shenzhen) Industrial Inc..

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
    I1607-305
  • Event Number
    2008EBC-0002562
  • Date
    2016-07-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=130
  • 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 states that it has detected the possibility that if the monitor is turned on continuously for several months, any displayed waveform will display outdated data, therefore, it will fail to reflect the current condition of the patient, however, alarms and numerical indicators are not will be affected, leading to possible adverse events on the patients.

Device

Multiparameter Monitoring Equipment Intellivue

Manufacturer

Witt Biomedical Corporation || Philips Medical Systems || Invivo Corporation || Philips Medizin S...
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA