Alerte De Sécurité sur Trade name: Patient lift. Technical Name: Patient Lift. ANVISA registration number: 80259110103. Class of risk: - Low Risk. Model Affected: Maximove. Serial numbers affected: 300044700; 300070780-300070791; 300050411; 300050413; 300072093; 300072094.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA.; ArjoHuntleigh AB.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2054
  • Date
    2016-10-03
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    As part of efforts to ensure customer satisfaction and product quality and performance, ArjoHuntleigh has decided to replace manual control for the Maxi Move floor lifts affected by this problem. This is not expected to affect the safety of the device, but its durability. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link . #### UPDATED ON 09/4/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Cause
    Premature wear of manual control. internal tests and research activities that conductive ink, which is necessary for activation of manual control function, did not meet the predetermined durability requirements.
  • Action
    Field Action Code TAN 07-2016 triggered under the responsibility of the company MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA. Company will make field correction as directed in the Letter to customers.

Manufacturer

  • Société-mère du fabricant (2017)
  • Source
    ANVSANVISA