Events

Alerte De Sécurité sur HAMILTON-T1 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 Hamilton Medical AG.

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
    2013-01-04
  • Date de publication de l'événement
    2013-01-04
  • 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_20130104a.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: hamilton medical ag hamilton-t1 ventilator it has come to our attention that medical device manufacturer, hamilton medical ag, has initiated a field safety corrective action concerning hamilton-t1 ventilator with software version <= 1.1.2. according to the manufacturer, there is unexpected high internal oxygen consumption of hamil ton-t1 ventilators during ventilation of small pediatric patients. the current labeling does not include sufficient information about the internal oxygen consumption of the ventilators. depending on the ventilator setting and the patient's lung impedance, the internal gas consumption of the hamilton-t1 may be higher than expected. the internal oxygen consumption has to be taken into account in addition to the oxygen requirements for the patient's ventilation, especially when oxygen is limited. if the available oxygen supply during transport is depleted, the life of the patient may be endangered. furthermore, the manufacturer will rework and provide updated hamilton-t1 labeling (e.G., operator's manual), and develop and provide updated software with optimized internal oxygen consumption and overall oxygen consumption monitoring. it also advises users to calculate the required oxygen capacity prior to transports. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 04 january 2013.

Device

HAMILTON-T1 Ventilator

Manufacturer

Hamilton Medical AG