Events

Alerte Ou Avis De Sécurité sur Welch Allyn AED 20

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par manufacturer #17429.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2007/085
  • Numéro de l'événement
    CON2032948
  • Date
    2007-11-07
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032948
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    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