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 Datex - Ohmeda Inc.

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 014 10 18 000
  • Event Initiated Date
    2018-10-07
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13262
  • 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
    Safety issue #1: upgraded aisys anesthesia devices and aisys cs2 anesthesia devices utilizing end-tidal control (etc mode) on rare occasions may lose ability to change fresh gas and agent settings when stopping the etc mode. safety issue #2: upgraded aisys anesthesia devices and aisys cs2 anesthesia devices with psvpro spontaneous breathing modes do not provide the psvpro ventilation mode feature of transitioning to simv pcv backup ventilation mode.

Device

Aisys and Aisys CS2 Anesthesia Devices
  • Model / Serial
    All upgraded Aisys anesthesia devices (i.e. Aisys devices upgraded to software version 11) and Aisys CS2 anesthesia devices (GTIN: 840682102292) with PSVPro option and/or End Tidal Control option. Software versions other than 11.00 and 11 SP01 are not affected.
  • Product Description
    Anesthesia Units
  • Manufacturer
    Datex - Ohmeda Inc

Manufacturer

Datex - Ohmeda Inc