Events

Safety Alert for multiparameter monitor for vital signs Ultraview SL Spacelabs

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Spacelabs Medical 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
    I1609-404
  • Event Number
    2009EBC-0003148
  • Date
    2016-09-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=120
  • 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 of failure to read non-invasive blood pressure (nibp) where the following errors may occur: no data, error of damage or hw error, which could lead to confusions of users and not signs of the patient are recorded.

Device

multiparameter monitor for vital signs Ultraview SL Spacelabs
  • Model / Serial
    ULTRAVIEW SL 91496 with command modules with option A, B, C, I ", lots 128280, 129940, 129420 and 155640.
  • Product Description
    Indicated for monitoring vital signs in patients in critical condition or observation. Use in hospital units (uci, surgery, emergencies, etc.) and ambulances.
  • Manufacturer
    Spacelabs Medical Inc

Manufacturer

Spacelabs Medical Inc