Events

Avis De Sécurité sur BVM (Bag-Valve-Mask) Manual Resuscitation Systems

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 Intersurgical Ltd.

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
    2017-06-05
  • 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
    There is a possibility the valve of the bvm manual resuscitation system may become stuck during storage. this could result in the intended tidal volume not being delivered through the valve, which may cause a delay in treatment. the instructions for use provided with these products include the requirement to ensure the bag, valve and oxygen delivery is functioning correctly prior to use. this field safety notice gives additional information relating to this specific problem and the additional actions required. .

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Modèle / numéro de série
    1. All lot numbers up to and including lot 370253 2. All lot numbers up to and including lot 1170673 3. All lot numbers up to and including lot 31753734 4. All lot numbers up to and including lot 170504
  • Manufacturer
    Intersurgical Ltd

Manufacturer

Intersurgical Ltd