Events

Alerte De Sécurité sur Oxylog 3000 and Oxylog 3000plus

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
    2016-12-12
  • Date de publication de l'événement
    2016-12-12
  • 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_20161212b.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 its oxylog 3000 and oxylog 3000plus. in december 2015 the manufacturer informed customers about an error condition observed in the market with products of the oxylog 3000 family, where the loss of contact of one of the control knobs generates an error message (previously referred to as “poti unplugged”). in these cases, acoustical and visual alarms are triggered, the breathing system releases pressure and the ventilation function stops operating. personal injury was not reported in any of these situations. the manufacturer’s investigations indicate that the error condition is caused by an oxide layer in the potentiometer. these oxide layers may accumulate over a longer period of time if various factor collude i.E. if the knobs are moved rarely or never. a verified remedy is repeated twisting of the knobs that removes the oxide layer. however, this particular error condition was still reported from the field after the safety notice. the remedy of twisting the knob is still considered effective. nonetheless, to reduce the impact of this special error condition the manufacturer has developed a new software that reduces the impact of the error condition. software version 1.06 will now be introduced for oxylog 3000pius, version 1.23 for oxylog 3000, respectively. the manufacturer will contact customers to schedule a time to perform the software update. according to the manufacturer, whenever a “control knob faulty” condition will occur with a device being equipped with the new software the device will continue to ventilate with the last valid settings, display for example the values for tidal volume in case of a defective potentiometer for vt and post the corresponding alarm. as reflected in the amended instruction for users, the customers are advised to check patient’s condition and the ventilation. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 12 december 2016.

Device

Oxylog 3000 and Oxylog 3000plus

Manufacturer

Draeger Medical GmbH