Events

Alerte De Sécurité sur Physio-Control LIFEPAK 15 Monitor/Defibrillator

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

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
    2017-02-10
  • Date de publication de l'événement
    2017-02-10
  • 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_20170210.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: physio-control lifepak 15 monitor/defibrillator the united states food and drug administration (fda) has posted a medical device safety alert concerning lifepak 15 monitor/defibrillator, manufactured by physio-control, with manufacturing dates from 3 september 2014 to 30 june 2016 and distribution dates from 13 september 2014 to 4 july 2016. the manufacturer is recalling the lifepak 15 monitor/defibrillator due to an electrical problem which may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. if the electrical shock is not delivered, the monitor will indicate “abnormal energy delivery” on the display. a delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death. for details, please refer to the following websites: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm540979.Htm http://www.Physio-control.Com/workarea/downloadasset.Aspx?id=2147498478 according to the local supplier, the affected product is not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 february 2017.

Device

Physio-Control LIFEPAK 15 Monitor/Defibrillator
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: Physio-Control LIFEPAK 15 Monitor/Defibrillator
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DH