Events

Alerte Ou Avis De Sécurité sur Arjo Minstrel passive floor lift (portable hoist)

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 ArjoHuntleigh AB.

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
    2019-01-30
  • Date de publication de l'événement
    2019-01-30
  • 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/arjo-minstrel-passive-floor-lift-portable-hoist-risk-of-spreader-bar-detachment-from-lifts-without-a-scale-mda-2019-004
  • 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 arjohuntleigh ab – spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient.
  • Action
    Check which version of the spreader bar your lifts have, using the manufacturer’s instructions in their Field Safety Notice (FSN).If your device requires replacement, please stop using it immediately, quarantine it and contact Arjo UK.If your device does not need replacement, fill in and return the customer response form in the FSN to Arjo UK to confirm this.

Device

Arjo Minstrel passive floor lift (portable hoist)
  • Modèle / numéro de série
  • Description du dispositif
    Affected devices were manufactured between January 2008 and March 2010 inclusive, with serial numbers shown in Appendix A of the FSN. The label contains the manufacture date.
  • Manufacturer
    ArjoHuntleigh AB

Manufacturer

ArjoHuntleigh AB
  • Adresse du fabricant
    Arjo UK Ltd Houghton Hall Business Park Houghton Regis Beds LU5 5XFUKSSUComplaintHandling@arjo.com
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    MHRA