Events

Alerte De Sécurité sur Schaerer® Surgical table Schaerer® Surgical table Surgical table Surgical table Surgical table Surgical table Schaerer® arcus 501 Schaerer® arcus 601 Surgical table Schaerer® arcus 701 Surgical table : AR-4815, AR-4816, AR-4817, AR-4818, AR-4819, AR-4820, AR-4829, AR-4842.

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 H. Strattner e Cia LTDA; Schaerer Medical AG.

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
    2271
  • Date
    2017-04-19
  • 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
    We recommend observing table movements carefully, and abnormally slow movements should be reported immediately to Schaerer customer service.
  • Cause
    Each schaerer arcus, 501, 601 or 701 surgical table is equipped with a large hydraulic valve block that is mounted to the top of the table column. this valve block is designed to control and coordinate the various hydraulic movements of the surgical table. during the routine quality control procedures at the valve block supplier's factory, inaccurate and out-of-specification drill holes were discovered. these holes serve as a positioner for the hydraulic valves, which control the hydraulic oil flow through the hydraulic system and thus control the movements of the table components. the inaccurate holes can result in damage to the valves, which can result in a table malfunction. the closing of damaged valves can result from an uncontrolled flow of hydraulic oil, which can result in a loss of pressure in the hydraulic pipes and, consequently, the cylinders may lose the correct control. this can result in a complete locking of the operating table in the position it is in.
  • Action
    Field Action Code TECNOVIG / AC / 01-2017 triggered under the responsibility of the company H. Strattner and Cia LTDA. Company will make correction in the field.

Device

Schaerer® Surgical table Schaerer® Surgical table Surgical table Surgical table Surgical table Su...

Manufacturer

H. Strattner e Cia LTDA; Schaerer Medical AG
  • Source
    ANVSANVISA