Events

Rappel de LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Physio-Control Australia Pty Ltd.

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-2017-RN-01389-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-11-08
  • 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-2017-RN-01389-1
  • 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
    Physio-control is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by cardinal health, does not meet physio-control’s specifications, and shows incorrect electrode placement for an infant. there is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. if the user incorrectly places the defibrillation electrodes it may result in ineffective energy delivery to the patient. this may result in failure to defibrillate and serious injury or death. there have been no reports of injuries associated with this issue.
  • Action
    Users are advised to inspect the "Electrode pouch and box labelling" and the "Electrode Starter Kit box labelling" to determine if the electrodes are affected. Users are advised to place of copy of the correct electrode packaging and labelling with each affected AED, until the electrodes have been replaced by Physio- Control.

Device

LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED...
  • Modèle / numéro de série
    LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connectorElectrodeCatalogue Number: 111401-000016MIN: 3202380-006Lot Numbers: 713609, 717912, 713904, 718033, 715008 and 719323Electrode Start KitsCatalogue Number: 11101-000017MIN: 3202784-009Lot Numbers: 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823 and 46078012ARTG Number: 232970
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Physio-Control Australia Pty Ltd

Manufacturer

Physio-Control Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA