Events

Rappel de HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation electrodes for use with the HeartSine Samaritan PAD 350P and 500P Defibrillators)

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-00655-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-06-18
  • 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-00655-1
  • 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
    During testing at heartsine technologies ltd, an issue has been detected with the seal on the foil pouch which contains the electrodes within the pad-pak and pedi-pak. on a small number, the final seal on the defibrillation electrode pouch was found to be difficult to open. the investigation identified that the supplier of the electrodes to heartsine technologies ltd had made a change to the manufacturing process which meant that an excessive amount of hot melt glue was applied to the final seal of the pouches.
  • Action
    Aero Healthcare is advising that all the affected units are within the control of the distributors. The distributors are advised that the affected units should be placed in quarantine to await collection by Aero Healthcare.

Device

HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation ele...
  • Modèle / numéro de série
    HeartSineTechnologies Pad-Pak/ Pedi-Pak (contains non-rechargeable battery and defibrillation electrodes for use with the HeartSine Samaritan PAD 350P and 500P Defibrillators)Lot Numbers: A1754, A1795, A1792, A1789, A1802 ARTG Numbers: 161839 (Adult Pad-Pak) and 161841 (Paediatric Pedi-Pak)
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare