Avis De Sécurité sur neoBLUE® blanket system performance

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 Natus Medical Incorporated.

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
  • Pays de l'événement
  • Source de l'événement
  • 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
    This notification is related to a prior notification and technical bulletin that you received around march 2015 regarding the neoblue blanket led phototherapy system. at that time, natus informed you of a potential issue of discoloration/degradation/melting of the fiber optic bundle at the pad connector which is inserted in the neoblue blanket light box. included with that letter was a technical bulletin which described the issue and addressed many of your potential questions. natus is in the process of confirming an updated neoblue blanket configuration which will not be susceptible to the degradation described above. however, the date of project completion is uncertain at this time. natus will contact you when the new configuration is available, at which time we intend to initiate a field corrective action to replace or upgrade your device(s). .