Events

Alerte Ou Avis De Sécurité sur Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Philips.

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
    Safety alert / Field Safety Notice
  • Date
    2018-11-29
  • Date de publication de l'événement
    2018-11-29
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/batteries-for-the-heartstart-mrx-monitor-defibrillator-may-fail-to-charge-or-to-provide-power
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
    This MDA is related to our previous alert, MDA/2018/002, advising users of a significant delay in the supply of batteries for the HeartStart MRx monitor/defibrillator.The supply of batteries for these devices has been halted again due to further manufacturing problems. There is likely to be an ongoing significant delay in the fulfilment of outstanding orders.
  • Cause
    Philips m3538a lithium-ion batteries manufactured from 28 december 2017 to 20 march 2018 inclusive for the heartstart mrx monitor/defibrillator may have an internal component failure.
  • Action
    Identify affected batteries highlighted in the manufacturer’s Field Safety Notice and remove them from service. Ensure alternative devices are available as defined in local risk assessment procedures until you can source a new battery. Follow the manufacturer’s instructions for use on battery management to keep your existing batteries in the best possible condition. Ensure there are systems in place to replace affected batteries as a priority when supplies are resumed.

Device

Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.
  • Modèle / numéro de série
  • Manufacturer
    Philips

Manufacturer

Philips
  • Adresse du fabricant
    Clare Fripp Head of Q&R Philips UK& Tel: 07920 763 640Email: clare.fripp@philips.com
  • Société-mère du fabricant (2017)
    Philips
  • Source
    MHRA