Events

Safety Alert Or Field Safety Notices for FRED easy Defibrillators manufactured by Schiller

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Schiller.

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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2012/042
  • Event Number
    CON172285
  • Date
    2012-07-11
  • Event Date Posted
    2012-07-11
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON172285?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    A false defibrillator error message, "transistor error", displays on screen and requires the device to be re-started. this problem may prevent shock delivery, which may result in failure to defibrillate and a reduced chance of survival for the patient. restarting of the defibrillator after display of a false error message may result in a delay to defibrillation. a software solution is either already available or under development, depending on the age of device. the older 1g units with serial numbers of 8 and 9 digits (manufactured from 2003 to 2006 inclusive) currently cannot be upgraded, as the software is under development. amazon medical will contact affected customers to provide further information, at a later date. for the remaining devices, the software will be deployed via a sd card for installation by users or the manufacturer.
  • Action
    Identify affected defibrillators; see manufacturer’s Field Safety Notice. MDA/2012/042 and MDA/2012/043 refer to this Field Safety Notice. If affected, contact Amazon Medical Ltd immediately for software upgrade deployment details. Provide Amazon Medical Ltd with up to date contact details via return of the fax back confirmation form in the FSN. Until software update is deployed, be aware of this problem which, if it occurs, can be rectified by a restart.

Device

FRED easy Defibrillators manufactured by Schiller
  • Model / Serial
  • Product Description
    FRED easy Defibrillators manufactured by Schiller. All devices are affected. Devices are distributed by Amazon Medical Ltd. Affected defibrillators: NOTE: FRED easyport is not affected Product All models Article number FRED easy Basic REF BR-FREDEASY FRED easy ECG on-screen REF BR-FREDEE FRED easy Manual REF BR-FREDEEM
  • Manufacturer
    Schiller

Manufacturer

Schiller