Events

Alerte Ou Avis De Sécurité sur HeartStart XL defibrillator/monitor with M3516A batteries

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/2013/066
  • Numéro de l'événement
    CON305480
  • Date
    2013-08-15
  • Date de publication de l'événement
    2013-08-15
  • 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/CON305480?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
    Seriousdefibrillator battery life has been reduced from 1.5 years to 1 year and the capacity test interval has been reduced from 6 months to 3 months. this applies to new batteries with the lot number prefix ‘lk’. philips is supplying an addendum with battery orders and heartstart xl monitor/defibrillator orders stating these changes (march 2013) to heartstart xl instructions for use (edition 7) and heartstart xl service manual (edition 6).
  • Action
    Ensure all relevant staff are aware of the changes. Ensure that the addendum (see appendix) is attached to the instructions for use and service manuals accordingly. Be aware that this addendum supersedes any previous guidance given by Philips regarding battery life and capacity test frequency.

Device

HeartStart XL defibrillator/monitor with M3516A batteries
  • Modèle / numéro de série
  • Description du dispositif
    HeartStart XL defibrillator/monitor with M3516A batteries of lot number with ‘LK’ prefix. Distributed by Philips and Cardiac Services UK & Ireland. NB: Philips HeartStart XL batteries with lot code prefixes ‘P’, ‘R’, and ‘PCS’ are not affected by this change and continue to have a life expectancy of about 1.5 years, when properly maintained and stored, and battery capacity test intervals of 6 months (for infrequent use) or 3 months (for frequent use).  These batteries are still supported with relevant instructions for use and labelling.
  • Manufacturer
    Philips

Manufacturer

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