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 Physio-Control 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 031 05 18 000
  • Event Initiated Date
    2018-05-09
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12582
  • 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
    Physio-control has become aware of an issue where the etco2 reading can intermittently show a value of “xxx” after start-up or during device operation. during the investigation, the manufacturer of the etco2 module found that compressed air may have contaminated filters within in the etco2 module. as a result of the contamination of the filter, the etco2 display on the lifepak 12 or lifepak 15 will provide a reading of “xxx”. there may be solid or dashed lines present on the device display in the place of an etco2 waveform and the service led will be illuminated. in this situation, the etco2 monitoring functionality will no longer be available.

Device

LIFEPAK® 15 and LIFEPAK® 12 with End-Tidal CO2 option
  • Model / Serial
    LIFEPAK® 15 Monitor/Defibrillator and LIFEPAK® 12 Defibrillator/Monitor with End-Tidal CO2 option
  • Product Description
    Monitor/Defibrillator
  • Manufacturer
    Physio-Control Inc.

Manufacturer

Physio-Control Inc.
  • Manufacturer Parent Company (2017)
    Stryker
  • Manufacturers representative
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA