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 Draeger 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 066 10 11 000
  • Event Initiated Date
    2011-10-23
  • Event Country
  • Event Source
    SFDA
  • Event Source URL
  • 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
    Ventricular fibrillation (vfib) arrhythmias will not be recognized by the monitor and will not alarm when the masimo set pod is used for spo2 measurements , there have been no patient injuries reported. our investigation determined that this condition is due to a software anomaly will result in the vfib alarm not sounding for any vfib arrhythmia condition that arises.

Device

  • Model / Serial
    Delta , Delta XL , Vista XL , Gamma XXL and kappa product MS18597,MS18596,MS18853,MS18986,MS18852 software versions are VF6.2,VF6.3 ,VF6.4,VF7.1 and VF7.2
  • Product Description
    Ventricular Fibrillation, Spo2 measurements
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturers representative
    International Medical Development Co. Ltd.
  • Source
    SFDA