Events

Alerte De Sécurité sur (Camara Range) / E.CAM Signature Series, record 10234230040, risk class III, lots / series: 550; 588; 1017; 3002; 3006; 3051; 4004; 4019; 4022; 5017; 5034; 5155; 7006; 7016; 7086; 7507; 8011; 8019; 8575; 8576; 8671; 9002; 9036; 10012. e.cam systems installed before December 31, 2004.

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 Siemens Ltda.; Siemens Medical Solutions USA, Inc..

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
    1651
  • Date
    2015-07-27
  • 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
    In addition to touch-key failure, enabling an e-stop or a system power failure between 0.05 and 0.1 seconds after the start of the movement, may cause this fault to occur. Even so, the record holder recommends reliably emergency stop.
  • Cause
    According to the record holder there is an account of unintentional movement of the sensor. the main cause of this movement was determined as a simultaneous failure of two components, the radial brake circuit and the touch keypad. this combination of failures resulted in shaft brake inefficiency, which gave rise to sensor movement.
  • Action
    The registration company directs customers to continue to use the equipment. It is recommended to observe the patient during the examination. The company has developed and will install an improved brake control circuit to correct this condition. You should ensure that this safety information is included in the instructions for use of the system. As usual, Siemens recommends observing the patient during the exams. If difficulties occur or a fault occurs while performing the daily touch-tone test, it is recommended to discontinue use and contact Siemens Technical Support. If unintended movement of the sensor is observed, remove the patient, interrupt the use of the system and contact Technical Assistance.

Device

(Camara Range) / E.CAM Signature Series, record 10234230040, risk class III, lots / series: 550; ...

Manufacturer

Siemens Ltda.; Siemens Medical Solutions USA, Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA