Events

Avis De Sécurité sur samaritan® PAD 500P (Public Access 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 HeartSine Technologies.

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
    SN2014(12)
  • Date
    2014-03-18
  • 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=/samaritan-pad-500p-(public-access-defibrillator)&id=32cdf925-9782-6eee-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
    Heartsine technologies is issuing a software upgrade to address an issue that could affect the accuracy of the cpr (cardiopulmonary resuscitation) instructions provided to rescuers by the samaritan® pad 500p during a sudden cardiac arrest situation.
  • Action
    The IMB recommends that:  1. Relevant personnel in your organisation are made aware of this potential issue.  2. Ensure that this IMB Safety Notice and the attached field safety notice is passed on to any organisation or end user where the potentially affected devices have been transferred.  3. Customers should contact either the local distributor or the manufacturer to schedule a service call out to upload the software upgrade to affected devices if a date has yet to be scheduled

Device

samaritan® PAD 500P (Public Access Defibrillator)
  • Modèle / numéro de série
  • Description du dispositif
    samaritan® PAD 500P (Public Access Defibrillator)
  • Manufacturer
    HeartSine Technologies

Manufacturer

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