Events

Alerte De Sécurité sur Giraffe Stand Alone Resuscitation Systems with Blender; Giraffe Warmer Integrated Resuscitation systems with Blender; Panda Warmer Integrated Resuscitation systems with Blender; Panda Freestanding Warmer Integrated Resuscitation Systems with Blender; and Resuscitation System field upgrade kits with Blender.

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
    2013-12-20
  • Date de publication de l'événement
    2013-12-20
  • 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_20131220.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 healthcare resuscitation systems the australia therapeutic goods administration (tga) posted a medical device safety alert concerning the following products manufactured by ge healthcare: giraffe stand alone resuscitation systems with blender; giraffe warmer integrated resuscitation systems with blender; panda warmer integrated resuscitation systems with blender; panda freestanding warmer integrated resuscitation systems with blender; and resuscitation system field upgrade kits with blender. the manufacturer has recently become aware of a potential safety issue associated with the loosening of the blender knob shaft on all resuscitation units. a loose blender knob shaft may potentially affect the accuracy of the blended output of air/ oxygen gas mixture from the unit which could result in hypoxia or hyperoxia. the manufacturer advises users to perform a blender accuracy check as outlined in the service manual to verify the oxygen concentration set at 21% and 100% settings are within the recommended range. if the blender accuracy test results do not meet specification, users are advised to remove the system from patient use and contact the manufacturer. if the blender accuracy results pass, the system is suitable for continued use. however, the manufacturer recommends that a pulse oximeter should be used to monitor the patient when delivering oxygen. the manufacturer will correct all affected systems as a permanent fix. for details, please visit the following tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01334-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 december 2013.

Device

Giraffe Stand Alone Resuscitation Systems with Blender; Giraffe Warmer Integrated Resuscitation s...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare Resuscitation Systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare