Alerta De Seguridad O Notificaciones De Seguridad para Spectra series powered wheelchairs

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Invacare.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
  • Número del evento
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Potential for wheelchair components to overheat in the event of a stall condition. this can occur when the control system is programmed with parameters different to those recommended by invacare. the manufacturer issued a field safety notice (fsn), dated 14 may 2013, but has not had confirmation from a significant number of customers that they have received and acted upon this information. in a stall condition, where the user is powering the wheelchair forwards or backwards and the wheelchair is prevented from doing so by an obstacle or rough terrain, there is potential for the wheelchair to overheat. where third parties have replaced (or amended the software parameters for) the joysticks or control modules and set the foldback parameters incorrectly, the chances of an overheat condition are increased.
  • Acción
    Ensure that those responsible for maintenance of these devices: identify affected devices assess and verify that the foldback parameters of the control system are correct as instructed in the FSN inform Invacare that the FSN has been received and the required action completed. The foldback parameters can be verified and adjusted using the current issue of the Dealer Level PC Programmer software from PG Drives Technology (Software Version – 11.3.0).  The latest version of the programmer software is available to download: Technical Manuals & Software Updates (external link) Contact Invacare for the correct original equipment manufacturer level programming file, and if required, for assistance obtaining the Programmer handheld device. The PG Pilot+ digital wheelchair control system should be set with the following Invacare defined foldback parameters: Current foldback time (seconds) - 15 seconds Current foldback level (%) - 25% PG Drives Technology have provided additional guidance for verifying and adjusting the foldback parameters: Using the Dealer Level PC Programmer (Software Revision 11.3.0) extract the current programming file from the Pilot+ control system using ‘Controller/read from controller’ in the toolbar and save it against the client’s name. This will preserve all the client specific changes that may have been made to speeds, accelerations or perhaps joystick-throw. Using the same Dealer Level PC Programmer open the OEM level programming file required for the chair, as provided by Invacare. This will contain the recommended current fold-back parameters for the chair. Click on the ‘Program’ shortcut on the programmer or select ‘Controller/Write to controller’ from the tool bar to update the programming file. Still using the same Dealer Level PC Programmer, once the Invacare file has been successfully uploaded to the controller, reopen the saved client file from step 1 and reprogramme the controller with these settings. This will overwrite just the dealer level parameters to ensure the chair will behave in the same way for the client as prior to the corrective action whilst the current fold-back parameters will remain as per the Invacare corrective action.


  • Modelo / Serial
  • Descripción del producto
    Spectra series powered wheelchairs Fitted with the Pilot+ digital wheelchair control system supplied by PG Drives Technology
  • Manufacturer