Events

Alerte Ou Avis De Sécurité sur SLE 4000/5000 ventilator, Power supply unit (PSU) model FP110-410

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 SLE.

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/2013/054R
  • Numéro de l'événement
    CON297494
  • Date
    2013-07-23
  • Date de publication de l'événement
    2013-07-23
  • 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/CON297494?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 component failure in the power supply unit (psu). failure of the psu will cause the ventilator to alarm and shut down immediately. the manufacturer issued a technical bulletin to its customers in february 2012, recommending replacing the psu. however, the mhra is uncertain whether corrective actions were carried out.
  • Action
    Locate all affected ventilators and inspect them to identify affected PSUs. Contact the manufacturer for a replacement PSU as soon as possible if the original PSU has not already been replaced. Inform SLE when the PSU has been changed or if the ventilator is not affected. Have an alternative ventilator on standby until any faulty PSUs are replaced. Check supplies to ensure that any spare PSUs are not affected.

Device

SLE 4000/5000 ventilator, Power supply unit (PSU) model FP110-410
  • Modèle / numéro de série
  • Description du dispositif
    SLE 4000/5000 ventilator. Power supply unit (PSU) model FP110-410. Specific serial numbers. Affected products can be identified as shown below: Affected product Ventilator model SLE 4000: Serial numbers 42040 and below Ventilator model SLE 5000: Serial numbers 53164 and below Power supply unit model FP110-410: Serial numbers from 163746 to 167558 inclusive Other model FP110-410 PSUs outside the above serial range may be affected if they contain ‘tall’ capacitors. These can be checked by following the recommendations in the manufacturer’s technical bulletin .
  • Manufacturer
    SLE

Manufacturer

SLE