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
    I1705-164
  • Event Number
    2008EBC-0002562
  • Date
    2017-05-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=89
  • 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 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...
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA