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 Hamilton Medical 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 048 02 11 000
  • Event Initiated Date
    2011-02-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=149
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    A software design error in the handling routine of the "high tidal volume" alarm (vt high alarm) in the adaptive volume/pressure ventilation modes (apvcmv and apvsimv) of the hamilton-g5/s1 ventilators.

Device

HAMILTON Ventilator
  • Model / Serial
    All HAMILTON G5 / HAMILTON-S1 ventilators with software version V2.00x and neonatal option or V2.01x and neonatal option.
  • Product Description
    Device that delivers a constant flow of oxygen/air to the patient, and provides the delivery of a maximum and a minimum airway pressure to the lungs during spontaneous breathing
  • Manufacturer
    Hamilton Medical Inc

Manufacturer

Hamilton Medical Inc
  • Manufacturer Parent Company (2017)
    Hamilton Bonaduz Ag
  • Manufacturers representative
    ABDULLA FOUAD HOLDING COMPANY , Dammam , (03) 832 4400
  • Source
    SFDA