Events

Alerte Ou Avis De Sécurité sur Babytherm infant warmers and open infant care units for newborns

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 Draeger 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
  • ID de l'événement
    MDA/2014/041
  • Numéro de l'événement
    CON467380
  • Date
    2014-10-21
  • Date de publication de l'événement
    2014-10-21
  • 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/CON467380?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 baby falling out of the device. failure to follow the instructions for use for inserting the inner safety panels and locking the outer safety side panels may result in them opening unexpectedly. draeger sent a field safety notice to its customers in august 2014 but hasn’t had enough replies to know if users have received and acted upon this information.
  • Action
    Identify affected devices. Ensure users read the important information in the Field Safety Notice (FSN) and follow the instructions (see appendix) to ensure that the inner safety panels are in place and the outer side panels are securely locked into position. If the locking mechanism is not functioning, contact Draeger. Complete the acknowledgement sheet you received with the FSN and return it to Draeger.

Device

Babytherm infant warmers and open infant care units for newborns
  • Modèle / numéro de série
  • Description du dispositif
    Babytherm infant warmers and open infant care units for newborns. Model numbers: 8004, 8010 and 8000WB. This device is an open care unit for warming premature babies, neonates and infants with a body weight of up to 8 kg.
  • Manufacturer
    Draeger Medical

Manufacturer

Draeger Medical