Events

Alerte De Sécurité sur AXIOM Luminos dRF Fluoroscopic X-ray System, Record No. 10234230153. Series numbers affected in Brazil: 3141; 3142; 3144; 3174; 4248; 4255

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..

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
    1388
  • Date
    2014-05-12
  • 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
    The company informs that the investigation conducted has determined that the described problem has been reproduced in cases of electrostatic discharge of more than 8kV that may be caused by a person close to the control console of the equipment. Only under extremely dry air conditions combined with a highly insulated floor can unintentional movement of the equipment be caused. However, the equipment meets the ESD safety requirements, according to IEC 61000-4-2 (36.202-2 Electrostatic discharge according to basic standard (+/- 6kV contact and +/- 8kV air).) Based on research and risk mitigation conducted by the manufacturer, it was detected that the root cause was that electrostatic discharges higher than 8kV can sporadically cause disturbances to the joystick sensors and consequently cause unintentional movements, such as inclination, and the probability of occurrence was considered improbable and its moderate severity, which fits this situation as a medium risk to health.As a corrective measure, Siemens is preparing an update to the control console of the Luminos dRF equipment in order to solve this potential malfunction. was identified on 2 devices within the overall installed base.
  • Cause
    The company has detected the possibility of a malfunction under rare environmental conditions (combination of extremely dry air with highly insulated floor) in which electrostatic discharges (esd) greater than 8kv in the control console of the equipment can cause an unintended movement in the system, which can lead to an emergency situation of risk to the patient (eg tabletop, compression), to the operator or to the equipment.
  • Action
    The company advises that in the event of an unintended movement immediately press one of the emergency red "STOP" buttons. The system will need to be restarted to return to full functionality. In addition, the customer must wait for the field staff to schedule field corrections and file the letter with the Operator's Manual.

Device

AXIOM Luminos dRF Fluoroscopic X-ray System, Record No. 10234230153. Series numbers affected in B...

Manufacturer

Siemens Ltda.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA