Events

Alerte De Sécurité sur MEDUMAT Transport Ventilator

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Weinmann Emergency Medical Technology GmbH & Co. KG.

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
    2013-10-22
  • Date de publication de l'événement
    2013-10-22
  • 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_20131022a.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: weinmann medumat transport ventilator the medicines and healthcare regulatory agency (mhra), united kingdom has posted a field safety notice concerning medumat transport ventilator (with and without co2 measurement) manufactured by weinmann emergency medical technology gmbh & co. kg. all the serial numbers are affected. according to the manufacturer, in some cases medumat transport ventilators have failed as a result of a device-internal fault. there is the potential risk of this fault recurring sporadically in future too. furthermore, according to the manufacturer, in the interaction of the internal structural components and sensors for internal device monitoring, device internal occurrences of this kind may coincide unfavourably, resulting in an undefined operating state and the device displaying a "device malfunction" for safety reasons. the manufacturer has developed new device software version 2.35. moreover, affected users are advised to take the following necessary actions: all medumat transport devices must be verifiably updated with the new xc firmware version 2.35 and embedded pc version 2.35. affected users can continue to use their medumat transport devices until the update has been installed. users are reminded to observe the recommendations and the addition to the instructions for use as mentioned in this field safety notice. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con323827 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 october 2013.

Device

MEDUMAT Transport Ventilator

Manufacturer

Weinmann Emergency Medical Technology GmbH & Co. KG