Events

Alerte Ou Avis De Sécurité sur IW900-series infant warmers

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 Fisher and Paykel Healthcare.

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
  • ID de l'événement
    MDA/2014/048
  • Numéro de l'événement
    CON491150
  • Date
    2014-12-18
  • Date de publication de l'événement
    2014-12-18
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON491150?tabName=allTabs
  • 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
    Risk of serious injury to the infant in the warmer the heater head may partially detach due to a manufacturing fault where the nut securing the heater head may break. fisher and paykel healthcare issued a field safety notice (fsn) dated 13 november and provided replacement nuts to customers affected but has not had enough replies to know that users have received and acted on this.
  • Action
    Follow the advice in the FSN to identify the infant warmers and any spare parts that may be affected. Replace affected nuts using the nuts supplied with the FSN. Contact Fisher & Paykel Healthcare if you are not sure about affected devices or how to replace the nut. Complete the FSN response form and return it to Fisher and Paykel Healthcare.

Device

IW900-series infant warmers
  • Modèle / numéro de série
  • Description du dispositif
    IW900-series infant warmers. Specific model and lot numbers are affected.
  • Manufacturer
    Fisher and Paykel Healthcare

Manufacturer

Fisher and Paykel Healthcare