Events

Alerte Ou Avis De Sécurité sur CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP

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 Maquet.

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
    2017-03-07
  • Date de publication de l'événement
    2017-03-07
  • 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/cardiosave-hybrid-intra-aortic-balloon-pump-iabp-and-cardiosave-rescue-iabp-damaged-lithium-ion-batteries-may-give-off-smoke-a-bad-smell-or-produce-sparks
  • 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
    Manufactured by maquet – until storage cases are available, avoid carrying spare batteries when transporting the iabp to reduce the risk of dropping and damaging them.
  • Action
    Identify affected batteries: they have part number 0146-00-0097 and were distributed from 12 December 2011 to 9 November 2016.Maquet’s Field Safety Notice (FSN) advises users not to take spare batteries when transporting the IABP until they receive a re-usable transport and storage case.Until the cases are available use an inverter and a transport AC power supply instead of carrying spare batteries.If these power supplies are not available, carry out an individual risk assessment for the continued use of the devices with batteries whilst in transport.Contact Maquet to acknowledge receipt of the FSNArrange for Maquet to provide (free of charge) warning labels to be applied to batteries and re-usable battery transport and storage cases.

Device

CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP
  • Modèle / numéro de série
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • Adresse du fabricant
    Hari Rajendran, Regulatory Affairs Officer, Maquet Ltd Tel: 0191 519 6200Email hariraj.rajendran@getinge.com
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    MHRA