Events

Safety Alert Or Field Safety Notices for Welch Allyn AED 20

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 manufacturer #17429.

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/2007/085
  • Event Number
    CON2032948
  • Date
    2007-11-07
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032948
  • 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
    Failure to defibrillate. the manufacturer is recalling a specific batch of these defibrillators to correct a malfunction that prevents or delays the delivery of therapy, which can lead to failure to resuscitate a patient. this recall is in addition to a batch of aed 20 defibrillators recalled in july 2006 to correct a similar malfunction (mda/2006/047). a malfunction is caused by an intermittent connection between a pin and socket on a circuit board inside the defibrillator. the problem develops over time and is unpredictable. the aed 20 has a self-monitoring feature that detects this problem and displays a ‘defib comm’ error message. the problem is often identified while the device is being tested before use but has also occurred while practitioners are attempting to use the device on a patient. the manufacturer issued recall letters to their distributors on 29 august 2007. this is an extension of a recall covered by mda/2006/047 issued in august 2006. the manufacturer is offering loan devices whilst those affected are being upgraded free of charge.
  • Action
    Identify affected devices using the list of serial numbers in the appendix. Contact the manufacturer to arrange service and upgrade as soon as possible. Consider if it is appropriate to substitute alternative defibrillators for those affected devices that are in service but are awaiting upgrade. If affected devices awaiting upgrade are used and display a ‘Defib Comm’ error message, the manufacturer has advised that switching the device off and then on again may clear the error message. The equipment maintenance records should be updated when upgraded units are returned.

Device

Welch Allyn AED 20
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Automatic external defibrillator - Welch Allyn AED 20. Welch Allyn AED 20 defibrillator with automated and manual mode options is distributed mainly in the UK by Response Medical Equipment Ltd. The affected devices can be identified by serial numbers located on the lower right hand corner of the back of the defibrillator. Affected units were manufactured between October 2003 and January 2005. Serial numbers of affected devices are listed in the appendix (in pdf only).
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429