Events

Alerte De Sécurité sur Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers

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

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
    2012-10-31
  • Date de publication de l'événement
    2012-10-31
  • 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_20121031a.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: ge resuscitation systems with blender field upgrade installed in ge giraffe and panda warmers the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning resuscitation systems with blender field upgrade installed in giraffe and panda warmers, manufactured by ge healthcare. according to the manufacturer, ge healthcare has recently become aware of a potential safety issue concerning the affected product where the oxygen and air wall inlet fittings and/or labels on the back panel, were reversed during assembly. as a result, this may potentially have reversed air/oxygen mixer concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. the settings of the blender knob will no longer be accurate. the manufacturer recommended users to follow the instructions shown in the field safety notice to identify the affected resuscitation system. regarding affected unit in use with patient, the manufacturer advised users to disconnect the wall supply gas and switch to tank supply. once the patient no longer requires respiratory support, the patient should be transferred to another bed and the unit should be removed from service. the manufacturer will also arrange on-site repair for all affected devices. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con195935 if you are in possession of the product, please contact your supplier for necessary actions. posted on 31 october 2012.

Device

Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare