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 Philips Healthcare.

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 006 12 14 000
  • Event Initiated Date
    2014-12-01
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6798
  • 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
    The mrx can be susceptible to one or both of the issues described below. 1. the co2 inlet port associated with end-tidal carbon dioxide (etco2) monitoring on mrx onitor/defibrillators can be pushed into the mrx housing, making it inaccessible. this can occur if the user attempts to push the co2 filterline fitting into the inlet port, instead of twisting it clockwise as described in the mrx instructions for use. 2. the handle can separate from the mrx housing due to breakage of mounts on the rear case.

Device

Philips HeartStart MRx Monitor/Defibrillator,
  • Model / Serial
    Product: Philips HeartStart MRx Monitor/Defibrillators Units Affected: MRx units meeting one or both of the conditions described in the “How to Identify Affected Products” section of this letter, AND with a serial number within the following ranges: Model M3535A: US00100100 to US00552845 Model M3536A: US00100902 to US00552848 Model M3536M: US00500002 to US00501201 Model M3536MC: US00500001 to US00500087 Model M3536M4: US00500003, US00500004, US00552673, US00552678, US00552679 Model M3536M5: US00500001 to US00552801
  • Product Description
    Monitor/Defibrillator
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA