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 Philips 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 023 01 15 000
  • Event Initiated Date
    2015-01-05
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6994
  • 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
    If the patient is connected to the anesthesia machine in a volume controlled ventilation mode, and attempts a large spontaneous breath, it is possible for the patient to create a high negative airway pressure around the same time as a volume controlled breath (mandatory breath).This pressure will be limited by the mechanical negative pressure limiter (npl) valve. the npl valve opens if the patient generates a negative pressure of -5 and -7.5 cmh20 (hpa). this opening pressure of the npl valve is defined at an inspiratory flow rate of 3.5-4.5 l/min. if the patient creates a higher flow rate than 4.5 l/min, the npl valve will continue to function but due to the resistance of the flow and time taken to reach the patient, the airway pressure may decrease further. the higher the flow generated by the patient, the greater the risk of increased negative airway pressure. if the patient is breathing spontaneously, support ventilation modes (vsv, psv) could be considered.

Device

Philip’s Anesthesia Machines ..
  • Model / Serial
    IntelliSave AX700 (P/N # 866205/10623-00) Dameca MRI 508 (P/N # 866203/10651MRI-00) Siesta i Whispa (P/N # 866202/10651-00) Siesta iTS (P/N # 866163/10653-00) Siesta Breasy (P/N # 866204/10652-00) All serial numbers are affected.
  • Product Description
    Anesthesia Machines
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA