Events

Avis De Sécurité sur Zoll AED Plus Defibrillator

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Zoll Medical Corporation.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2009(13) Updated Version
  • Date
    2011-05-23
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/zoll-aed-plus-defibrillator&id=6e86f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notes supplémentaires dans les données
  • Cause
    The zoll aed plus defibrillator may not deliver therapy.
  • Action
    1. Ensure that the relevant personnel in your organisation are made aware of this  issue.  2. Determine if you have purchased the affected serial numbers of this product,  AED Plus devices with serial numbers below X_ _ _200000.  3. If you have an affected device confirm that the recommended actions have been completed:  Ensure that the date when the batteries were installed in your device has been checked.  a. If batteries were installed more than three (3) years ago, replace the batteries  as soon as possible and add the label provided by Zoll showing the next  scheduled replacement date. Read and add the addendum incorporating this  information to the administrator’s guide that was provided by Zoll.  b. If batteries are not more than three (3) years old, add the label provided by  Zoll completed with the next scheduled replacement date. Read and add the  addendum, provided by Zoll, incorporating this information to the  administrator’s guide.

Device

Zoll AED Plus Defibrillator

Manufacturer

Zoll Medical Corporation