Events

Rappel de Samaritan PAD 500P (Public Access Defibrillator)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Aero Healthcare.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00243-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00243-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    The software in the affected samaritan® pad 500p 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.
  • Action
    Aero Healthcare is advising users not to remove devices from service. Aero Healthcare is advising users that to address the issue an updated software version is available on the HeartSine Technologies website for download. Please follow the instructions provided by Aero Healthcare to download the new software. Alternatively, Aero Healthcare can provide an upgrade kit which includes a CD with the updated software version.

Device

Samaritan PAD 500P (Public Access Defibrillator)
  • Modèle / numéro de série
    Samaritan PAD 500P (Public Access Defibrillator) Serial Numbers: 10B0010001 to 14B00461703Manufactured between February 2010 and January 2014ARTG Number: 156690
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare