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 003 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=6795
  • 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 could contain incorrect internal software settings, causing the following two issues: 1. the device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended. 2. while connected to ac or dc power and with no battery installed or the battery installed has a charge level of less than 10%, the ready for use (rfu) indicator will not provide the expected low battery indication (flashing red x with audible chirp). instead, the rfu will show a flashing black hourglass, indicating that sufficient battery power is available for device operation.

Device

Philips HeartStart MRx Monitor/Defibrillator..
  • Model / Serial
    Product: Philips HeartStart MRx Monitor/Defibrillators Units Affected: MRx units, models M3535A and M3536A, with the following serial numbers: US00101159, US00533518, US00322848, US00533521 through US00535118, US00326834, US00539526, US00328432, US00540124, US00328439, US00543102, US00328442, US00543104, US00328443, US00543138, US00328446, US00543158, US00328450, US00543161, US00328461, US00543166, US00328464, US00543167, US00328465, US00543187, US00328468, US00543204, US00328473, US00543223, US00328478, US00543239, US00330393, US00546804
  • 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