Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by GE Healthcare.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 054 11 18 000
  • Event Initiated Date
    2018-11-20
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13501
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The following issues may occur when multiple carescape b850 monitors are connected to the same network and a network overload occurs for a prolonged time due to network misconfiguration: 1. loss of carescape b850 monitor connection with patient data module (pdm) or carescape one (cs one) module 2. restart of carescape b850 monitors using automatic view on alarm (avoa) functionality.

Device

CARESCAPE B850 MBC303 monitors
  • Model / Serial
    CARESCAPE B850 monitors of version MBC303
  • Product Description
    Patient monitor
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare