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 Heinen & Loewenstein.

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 143 09 12 000
  • Event Initiated Date
    2012-09-19
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2398
  • 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
    During the uninterrupted operation of the leoni plus for more than 49 consecutive days the device may start a highest priority alarm that results in a continuous alarm sound and a visual alarm on the monitor. as a consequence of this the ventilation will be interrupted preventing potential hazards for the patient. this situation is just a potential scenario that may appear in rare cases where the devices are continuously operated and put into the standby mode during periods not being connected to the patient but never shut down completely during a period of 49 days.

Device

Ventilator, neonatal/paediatric, Leoni plus
  • Model / Serial
    Serial no.: 0217001xxx, 0217004xxx; Software Version 1.x.x and 2.2.x.;
  • Product Description
    Ventilator, neonatal/paediatric
  • Manufacturer
    Heinen & Loewenstein

Manufacturer

Heinen & Loewenstein
  • Manufacturer Parent Company (2017)
    Löwenstein Familien-Stiftung
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA