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 Draeger Medical Systems 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 071 04 18 001
  • Event Initiated Date
    2018-11-15
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13497
  • 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
    Our continuous post market surveillance has shown that some users have concerns about the method used by the jm-103 to indicate that a taken measurement is out of ränge (higher than the measuring ränge of the device). as described in the instructions for use and in the device’s training materials, the jm-103 displays a blinking “—“ when the measurement is out of ränge. the measuring ränge is defined to 340 pmol/l / 20 mg/dl.

Device

Jaundice Meter JM-103 and JM-105 Out of Range Indication

Manufacturer

Draeger Medical Systems Inc
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Manufacturers representative
    Draeger Arabia Co. Ltd.
  • Source
    SFDA