Events

Alerte Ou Avis De Sécurité sur V60 ventilator

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 Philips Respironics.

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
  • Date
    2017-05-17
  • Date de publication de l'événement
    2017-05-17
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/v60-ventilator-potential-for-unexpected-shutdown
  • 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
    Manufactured by philips respironics – faulty software can cause false alarms for stalled blower motor, leading to unexpected shutdown.
  • Action
    Identify all devices with software version 2.20 (which may have been upgraded by some customers between 17 April 2016 and 4 January 2017) as per Philips’s FSN 86600036A. Ensure either hospital biomedical engineers or Philips field service engineers install the correct software (version 2.10). Philips advise in their FSN that devices with software version 2.20 should not be used unless close clinical observation is available. If alternative devices are unavailable, carry out an individual risk assessment for the continued use of the devices with version 2.20 software until version 2.10 can be installed. Contact Philips Respironics to acknowledge receipt of the FSN.

Device

V60 ventilator

Manufacturer

Philips Respironics
  • Adresse du fabricant
    Mr Michael Turvey Q&R Officer Philips Health Systems Telephone: 0870 532 9741Email: michael.turvey@philips.com
  • Société-mère du fabricant (2017)
    Philips
  • Source
    MHRA