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 Schiller AG.

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 161 03 16 000
  • Event Initiated Date
    2016-03-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9086
  • 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
    Schiller ag have received an incident report of fred easyport where the ecg trace showed a ventricular fibrillation. fred easyport decided for a shock delivery correctly. during the loading of capacitor fred easyport analyzed further and due to the short change of rhythm fred easyport diverted the shock internally and asked the user to resume cpr (cardiopulmonary resuscitation) immediately.

Device

FRED Easyport
  • Model / Serial
    Model 0.900000 S/N: all
  • Product Description
    Non-rechargeable public semi-automated external defibrillator
  • Manufacturer
    Schiller AG

Manufacturer

Schiller AG
  • Manufacturer Parent Company (2017)
    Schiller Holding Ag
  • Manufacturers representative
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA