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
    2015-12-28
  • Date de publication de l'événement
    2015-12-28
  • 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_20151228b.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 medical device manufacturer, draeger medical gmbh, has issued a medical device safety alert concerning oxylog transport ventilators manufactured by draeger medical. the affected model numbers are oxylog 2000plus, oxylog 3000 and oxylog 3000plus. the manufacturer has become aware of situations where the error message “poti unplugged" was generated. in those cases, an audible and visual alarm is generated, the breathing system releases pressure and the ventilation function stops operating. according to the manufacturer, no patient injury has been reported due to the issue. the error message is caused by increased electrical contact resistances of the controllers (adjustment potentiometers) that are caused by an oxide layer on the controllers, which accumulates over a longer period of time if the controllers are moved rarely or never. the manufacturer’s product monitoring has shown that some users rarely use the fio2 controller or do not use it at all. as a preventive measure, the manufacturer highly recommends to move all controllers once when the affected device is switched off; at least 10 times to the left and right stop (minimum and maximum value). this measure suffices to clean the resistance taper of the controllers sufficiently. in particular with the error “device malfunction – poti unplugged”, the aforementioned method can also be used to put the device back into operation. the manufacturer reminds users that the affected devices must only be used after verifying its operational readiness. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the following link:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-01256-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 28 december 2015.

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