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
    2017-12-22
  • 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
    A manufacturing fault has been identified with the intersurgical bvm manual resuscitation system, which could result in the directional valves positioned on the ‘back plate’ of the self- inflating bag being orientated incorrectly. the images show the incorrect and correct orientation of the directional valves. the incorrect orientation of the directional valves could result in the bvm manual system becoming over pressurised, which could result in patient barotrauma.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Modèle / numéro de série
    7150000 – 363791, 370252, 370751, 371638, 372887, 372894, 375508 7151000 – 364909, 370253, 371091, 371639, 372886, 372890, 375711 7152000 – 363792, 364270, 364923, 365216, 370266, 370752, 371640, 371656, 372888, 372889, 372893, 373638, 373639, 375411 7152005 – 31753284, 31756956, 31757575 7152006 – 31660106, 31753127, 31756716, 31757576, 31758289 7152007 – 371092 7152012 – 31753733, 31756957 7153000 – 363793, 370738, 371907, 372892, 375509 7153008 – 31753734 7154000 – 370753, 372367
  • Manufacturer
    Intersurgical Ltd

Manufacturer

Intersurgical Ltd