Events

Alerte De Sécurité sur Oxylog Transport Ventilators

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

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
    2014-02-20
  • Date de publication de l'événement
    2014-02-20
  • 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_20140220b.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: draeger oxylog transport ventilators the australia therapeutic goods administration (tga) posted a medical device safety alert concerning oxylog transport ventilators manufactured by draeger medical. the affected model numbers are oxylog 3000plus and oxylog 2000plus, and the affected serial numbers are asej-0138 and asek-0011. the manufacturer has received reports of devices displaying the error message “poti unplugged”. the investigation has revealed that a limited batch of faulty control panel pcbs - onto which the potentiometer for setting the ventilation parameters is soldered. this can result in the contact to the respective potentiometer being interrupted. the device then discontinues ventilation, gives an audible alarm and displays the error message poti unplugged. the manufacturer advises users that if this error occurs they must immediately commence ventilation using an independent ventilator (manual ventilation bag) as specified in the instructions for use manual. furthermore, the manufacturer will be contacting all affected users to organise the correction of the affected devices. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00168-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 february 2014.

Device

Oxylog Transport Ventilators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Draeger Oxylog Transport Ventilators
  • Manufacturer
    Draeger Medical GmbH

Manufacturer

Draeger Medical GmbH