Events

Alerte Ou Avis De Sécurité sur BVM (Bag-Valve-Mask) manual resuscitation systems

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 Intersurgical.

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
    2017-06-21
  • Date de publication de l'événement
    2017-06-21
  • 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/bvm-bag-valve-mask-manual-resuscitation-systems-risk-of-delay-to-emergency-treatment
  • 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 intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.
  • Action
    Identify all affected devices – see details below. Search for alternative devices to replace affected products (see appendix), and until alternative devices are available follow the guidelines in the Field Safety Notice. Once you have alternatives, quarantine the affected devices and contact Intersurgical.

Device

BVM (Bag-Valve-Mask) manual resuscitation systems
  • Modèle / numéro de série
  • Description du dispositif
    The following model (REF number) and LOT numbers are affected:REF number LOT number NHS Supply Chain Code 7150000, 7151000, 7151001, 7152000, 7152007, 7152060, 7153000, 7154000, 7155000, 7156000 All lot numbers up to and including lot 370253 7150000 is FDE656, 7152000 is FDE658, 7153000 is FDD4288 7152003 All lot numbers up to and including lot 1170673 n/a 7150006, 7151006, 7152004, 7152005, 7152006, 7152009, 7152012, 7152014, 7152061, 7153006, 7153008 All lot numbers up to and including lot 31753734 n/a 7150170, 7151170, 7152170, 7152172, 7153170 All lot numbers up to and including lot 170504 n/a
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical
  • Adresse du fabricant
    Chris Randall IntersurgicalTelephone: 0118 9656 362Fax: 0118 9656 356Email: priority@intersurgical.co.uk
  • Société-mère du fabricant (2017)
    Etablissement Cosmeplast
  • Source
    MHRA