Events

Alerte Ou Avis De Sécurité sur HeartStart XL defibrillator/monitor

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
  • ID de l'événement
    MDA/2012/077
  • Numéro de l'événement
    CON203886
  • Date
    2012-11-08
  • Date de publication de l'événement
    2012-11-08
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON203886?tabName=allTabs
  • 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
  • Cause
    Risk of immediate and unexpected loss of critical monitoring, defibrillation or non-invasive pacing. if a heartstart xl defibrillator/monitor is not connected to the mains and is used with a battery from the affected batch, it may shut down unexpectedly without providing the user with a low battery warning or audible alarm. the manufacturer published a field safety notice in september 2012 to notify users and prompt them to take action.  the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon.
  • Action
    Identify HeartStart XL defibrillator/monitors with affected batteries and affected spare batteries. If you have affected batteries, follow the guidance given in the Field Safety Notice. In particular: do not use device on battery power alone, and ensure you have access to an appropriate alternative device. Contact the manufacturer to arrange for a replacement battery.

Device

HeartStart XL defibrillator/monitor
  • Modèle / numéro de série
  • Description du dispositif
    Batteries for HeartStart XL defibrillator/monitor. Battery part number M3516A. Batch labelled ‘Made in Taiwan’ with ‘Date of Manufacture’ code ‘R-2011-12’.
  • Manufacturer
    Philips

Manufacturer

Philips
  • Société-mère du fabricant (2017)
    Philips
  • Source
    MHRA