Events

Avis De Sécurité sur Li-Ion Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia 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
    Field Safety Notice
  • Date
    2016-12-23
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Maquet continually monitors the performance of the cardiosave iabps and has discovered an issue that could affect the li-ion battery used with the cardiosave iabp. if the li-ion battery is accidently dropped, the impact may cause the battery to vent. in addition to the risks contained in the warnings section of the operator/user instructions, battery venting has the potential to create smoke, a foul odor, and sparks. it is important to note that to date, there has been no reported patient harm or adverse events attributable to this issue. of the more than 8,000 li-ion batteries distributed worldwide, to date, there have been 3 reported occurrences of the battery venting when dropped. .

Device

Li-Ion Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP
  • Modèle / numéro de série
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    AMPMDRS