Events

Alerte De Sécurité sur FRED Easyport

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Schiller.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-05-18
  • Date de publication de l'événement
    2016-05-18
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160518c.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: schiller fred easyport the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning fred easyport (an automatic external defibrillator) manufactured by schiller. the affected article number is 0.900000 and the affected products are sold from 2004 to 2016. according to the manufacturer, the device can be categorised into three categories according to its configuration: first category: has manual mode of analysis and can override the analysis in order to shock based on user’s decision. second category: has manual mode of analysis and shock delivery by user, if suggested by the device. analysis cannot be overridden but can be initiated again at any time.  third category: does automatic analysis every two minutes which cannot be overridden by user. the manufacturer has received an incident report relating to a device of the third category where the ecg trace showed a ventricular fibrillation. the device decided for a shock delivery correctly. during the loading of capacitor the device analysed further and due to the short change of rhythm the device diverted the shock internally and asked the user to resume cardiopulmonary resuscitation (cpr) immediately. the device in question (third category) had a special feature of automatic analysis every two minutes. however, the standard device (first and second categories) analyses upon pressing the “analysis” button. the user is prompted to do so every two minutes. in the present case the user got confused and did not allow for the further automatic rhythm analysis after two minutes. the user continued with cpr, so the device noted motion artefacts and thus could not analyse the trace anymore. therefore, no shock was delivered. the manufacturer advises that:- for the first and second categories of device: users can use the device without any restriction. however, new software upgrade to ver. 3.14 is recommended at next service of device. for the third category of device: new software upgrading shall be completed upon receipt from the manufacturer of the new software version 3.14. with the new software version 3.14, there will be no automatic re-analysis during charging of capacitor; therefore, this potential risk will be eliminated. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-9-may-13-may-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 may 2016.

Device

FRED Easyport
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Schiller FRED Easyport
  • Manufacturer
    Schiller

Manufacturer

Schiller