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 033 11 18 000
  • Event Initiated Date
    2018-11-12
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13476
  • 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
    Certain mrx m3538a lithium-ion batteries may contain a defective component should the component fail, the battery will no longer charge or deliver power to the mrx monitor/defibrillator, which may prevent operation of the device if a second charged battery is not installed or if the device is not connected to ac or dc power. additionally, the led status indicator on the battery will not illuminate, even if the battery has a charge. should a second, unaffected battery be present in the heart5tart mrx, the battery failure may go unnoticed.

Device

Philips HeartStart MRx M3538A
  • Model / Serial
    Product: M3538A Lithium-Ion Batteries for the HeartStart MRx Monitor/Defibrillator Units Affected subject to thi5 Recall: A total of 1,880 Lithium-Ion Batteries manufactured between January 1gth, 2018 and March 20th, 2018 with serial numbers 17362-0001-P through 18057-0266-P
  • Product Description
    Patient Monitoring
  • Manufacturer
    Philips Healthcare

Manufacturer

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