Events

Alerte Ou Avis De Sécurité sur Cook Vacuum Pump for IVF

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 Cook Medical.

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
    2018-05-24
  • Date de publication de l'événement
    2018-05-24
  • 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/cook-vacuum-pump-for-ivf-risk-of-electric-shock-or-burn-to-operator
  • 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
    The manufacturer identified that the internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard IEC60601-1 Edition 3.0.The potential hazardous situations which could arise as a result of this include; failure of the device to operate or electric shock or burn to the user.
  • Cause
    Manufactured by cook medical – risk of electric shock or burn, and failure of the device to operate during ivf procedures because of non-compliant mains wiring.
  • Action
    Identify the affected devices as stated in device details and, in the manufacturer’s, Field Safety Notice (FSN). Ensure that all users receive the manufacturer’s FSN and that they understand the problem. Ensure a residual current device (RCD), which is marked stating its compliance with BS 7071, is fitted to the mains electricity supply to mitigate the risk of a hazardous situation. RCDs are also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an appliance leakage current interrupter (ALCI). If you do not have access to an RCD (or equivalent) do not use the vacuum pump until the mains wiring for the unit has been replaced by the manufacturer. If an adverse event occurs relating to this issue please report this to the MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Device

Cook Vacuum Pump for IVF
  • Modèle / numéro de série
  • Description du dispositif
    Product Name Reference Part Number Global Product Number Lot Numbers Cook Vacuum Pump™ K-MAR-5200 G49275 All lots
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical
  • Adresse du fabricant
    Cook Medical Ms. Sinead BurkeTel: +353 (0)61 334440Sinead.burke@CookMedical.com
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    MHRA