Events

Alerte De Sécurité sur Trade Name: SURGICAL TABLE; Model MAGNUS 1180; registration: 80259110066; risk class I; Series numbers affected in Brazil-distributed in the Municipality of São Paulo-SP: 99; 142; 144; 145 distributed in the Municipality of Rio de Janeiro-RJ: 239; 241; 243.

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 MÉDICOS LTDA.; MAQUET GMBH.

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
    1855
  • Date
    2016-03-18
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Recommendations to users and patients: Check at the time of use of the equipment whether the basic table top is locked on the conveyor or if it needs to be transferred to the conveyor, make sure that the extension device is attached to the side opposite the battery holder and conveyor handle bar.
  • Cause
    Maquet within the scope of market surveillance has learned that, due to improper handling under unfavorable circumstances, the magnus 1180 table extension device can be unlocked from the tabletop and fall. this problem may occur when the device is not used according to the description in the instructions for use and the operator does not pay attention to possible collisions. in extreme cases, collisions with an obstacle under the tabletop can lead to the problem described above. the extension device may from the operating table mounting point if: • the table top with mounted accessories is moved against obstacles; • the assembled table top with accessories is transferred to the conveyor incorrectly with the foot and head ends inverted.
  • Action
    Code of the action CAPA 2016-002. Send of letter of report for the customers that have equipment affected ////// Sending of technicians to the place of equipment affected for installation of new accessory.

Device

Trade Name: SURGICAL TABLE; Model MAGNUS 1180; registration: 80259110066; risk class I; Series nu...

Manufacturer

MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET GMBH
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    ANVSANVISA