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 117 06 18 000
  • Event Initiated Date
    2018-06-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12826
  • 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 neonatal flow sensor cable may be missing the connector housing exposing the wires in the cable. if the exposed wires break, primary ventilation parameters could be lost (flow and tidal volume). this issue may cause indirect but reversible changes in the patient’s condition as these parameters, among other information, are used in choosing appropriate ventilator settings for the patient.

Device

CARESCAPE R860, ENGSTROM CARESTATION and ENGSTROM PRO
  • Model / Serial
    Neonatal Flow Sensor Cable (1505-5604-000 Lot # 1804) used on CARESCAPE R860 1506-8600-000, ENGSTROM Carestation 1505-9000-000, Engstrom Pro 1505-9003-000. Contained in Neonatal Software Upgrade Kit 2080496-010.
  • Product Description
    Ventilator
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare