Events

Alerte De Sécurité sur Samaritan PAD 500P Automated External Defibrillators

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

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
    2014-03-04
  • Date de publication de l'événement
    2014-03-04
  • 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_20140304a.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: heartsine samaritan pad 500p automated external defibrillators the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning samaritan pad 500p automated external defibrillators, manufactured by heartsine technologies, inc. the affected serial numbers ranged from 10b0010001 to 14b00461703, manufactured between february 2010 and january 2014. according to the manufacturer, the software in the concerned defibrillators may miscalculate the cpr rate of compression per minute being administered to the patient. the rescuer may, therefore, be incorrectly advised by the device to “push slower” when, in fact, the cpr rate is at an acceptable level. to address the issue, the manufacturer has posted an updated version of the software for the samaritan pad 500p on the heartsine technologies website for download. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con382708 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 04 march 2014.

Device

Samaritan PAD 500P Automated External Defibrillators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: HeartSine Samaritan PAD 500P Automated External Defibrillators
  • Manufacturer
    HeartSine Technologies

Manufacturer

HeartSine Technologies
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DH