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 Arjo Huntleigh.

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 082 05 13 000
  • Event Initiated Date
    2013-05-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=3638
  • 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
    The manufacturer conducted field safety correction actions in canada between 2004 and 2007 to provide improved safety instructions and warnings to reduce the risk of the alenti chair tipping and patient falls. the incident rate has since declined. however, the manufacturer continues to receive several incident reports in canada each year. since august 2012, there have been nine tipping and patient slide-out incidents reported in canada. two of these were associated with patient deaths ( more details in attached file ).

Device

Integrated bathing system, Alenti
  • Model / Serial
    SN : CDB8003-01, CDB8053-01, CDB8103-01, CDB8153-01
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    Part of an integrated bathing system, Alenti™ provides transport and transfer solution for semi-dependent residents.
  • Manufacturer
    Arjo Huntleigh

Manufacturer

Arjo Huntleigh
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Manufacturers representative
    Al-Faisaliah Medical System
  • Source
    SFDA