Events

Alerte Ou Avis De Sécurité sur ConchaTherm Neptune heated humidifiers

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 Teleflex.

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/2012/068
  • Numéro de l'événement
    CON185606
  • Date
    2012-09-25
  • Date de publication de l'événement
    2012-09-25
  • 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/CON185606?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
    Potential for failure of the speaker. if the speaker fails, no alarm will sound in the event of a device failure, which could cause a delay in patient treatment. the manufacturer published a field safety notice (fsn), in june 2012 to notify users and prompt them to take action.  the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon. although the speaker failure will result in no alarm sounding if there is a problem, the humidifier will continue to detect any abnormalities and take appropriate action.
  • Action
    Locate and identify all affected devices using the list of serial numbers in the manufacturer’s FSN. Check the speaker by following the instructions in the manufacturer’s FSN. Return the acknowledgement form to Teleflex. If faulty speakers are found, contact Teleflex immediately to request replacement speakers as a priority. For future use, be aware that if the humidifier makes neither an audible alert nor alarm as part of the self-check on startup, there may be a fault with the speaker.

Device

ConchaTherm Neptune heated humidifiers
  • Modèle / numéro de série
  • Description du dispositif
    ConchaTherm Neptune heated humidifiers. Product codes: 425–00, 425–10 and 425–30. Specific serial numbers. This heated humidification system is designed to heat and humidify respiratory gases delivered to adult and paediatric patients.
  • Manufacturer
    Teleflex

Manufacturer

Teleflex