Events

Alerte Ou Avis De Sécurité sur FRED easy Defibrillators manufactured by Schiller

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 Schiller.

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/2012/042
  • Numéro de l'événement
    CON172285
  • Date
    2012-07-11
  • Date de publication de l'événement
    2012-07-11
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON172285?tabName=allTabs
  • 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
    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
  • Modèle / numéro de série
  • Description du dispositif
    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