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 123 02 18 000
  • Event Initiated Date
    2018-02-26
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12202
  • 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
    Philips has become aware of a specific issue with one of the electric components (a resistor) in approximately 660,000 aeds that were manufactured between 2002-2013. virtually all of these resistor-related failures were detected through the device’s automatic self-testing, alerting the user by issuing audible chirps. the in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest victim is in need of shock therapy. however, in rare instances, self-tests might not identify a problem and the device might not deliver a shock when needed. to date, philips is aware of 13 instances in which this component failed during treatment, out of more than 45,000 uses in which shock therapy was delivered. in all these instances, the device delivered at least one shock before failure. among the cases for which the patient outcome is known, 5 patients died and 2 patients were successfully resuscitated and survived. importantly, when aeds are used on patients suffering sudden cardiac arrest, not all patients survive. in published studies of public access defibrillation to treat sudden cardiac arrest, the typical indicated survival rates are approximately 25% when an aed is used by a bystander versus 10% if an aed is not used.

Device

HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs
  • Model / Serial
    Philips AED Models: HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs manufactured from September 2002 through February 2013 are included within the scope of this notification because they may contain the type of resistor that has previously been associated with a failure. The year of manufacture can be identified by the 2nd and 3rd characters in the serial number on the back of the AED in the range: Home/Onsite:(02)I-xxxxx through A 13(B-)xxxxx FRxB(04)L-xxxxx through B13(B-)xxxxx
  • Product Description
    Defibrillator/Cardioverters
  • Manufacturer
    Philips Healthcare

Manufacturer

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