Events

Alerta De Seguridad O Notificaciones De Seguridad para SCHILLER FRED AED: Defibrillation Electrodes

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 Schiller.

¿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
    MDA/2012/043
  • Número del evento
    CON172294
  • Fecha
    2012-07-11
  • Fecha de publicación del evento
    2012-07-11
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON172294?tabName=allTabs
  • 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
    Premature drying up of electrodes due to a manufacturing quality problem. this may prevent shock delivery, which may result in failure to defibrillate and a reduced chance of survival for the patient. users have reported that these electrodes partially dry up before their expiry date, possibly due to variations in the manufacturing process. if the electrodes partially dry up, there is a risk that they will not be detected by the defibrillator, as their impedance is too high.
  • Acción
    See manufacturer’s Field Safety Notice issued May 2012 by Amazon Medical Limited. MDA/2012/042 and MDA/2012/043 refer to this Field Safety Notice. Check inventory and identify affected electrodes. If affected, immediately contact Amazon Medical Limited for replacement electrodes. Return the fax back confirmation form in the FSN to Amazon Medical Limited.

Device

SCHILLER FRED AED: Defibrillation Electrodes
  • Modelo / Serial
  • Descripción del producto
    Schiller electrodes: silver packet, manufactured by Nessler Medizintechnik. All (Paediatric and Adult) devices are affected. Devices are distributed by Amazon Medical Ltd. The electrodes (example, right) are supplied with the FRED defibrillators or can be acquired as an accessory. All those electrodes produced before January 2011 are affected. SCHILLER FRED AED: Defibrillation Electrodes - Nessler Medizintechnik Product Article number FRED defibrillation electrodes Adult REF W1410241 FRED defibrillation electrodes Child Same packet – labelled Child REF W1410262 Schiller Fred easyport, APLC1 & APLC2 Defibrillation Electrodes – Nessler Medizintechnik Product Article number FRED easyport defibrillation electrodes - Adult Same size packet as 2.155057 REF 2.155056 FRED easyport defibrillation electrodes - Child REF 2.155057 APLC1 & APLC2 defibrillation electrodes Adult REF 0‐21‐0024 Schiller Fred easy Defibrillation Electrodes – Nessler Medizintechnik Product Article number FRED easy defibrillation electrodes REF 0-21-0003 FRED easy REF 0-21-0020 FRED easy REF 0-21-0000 FRED easy REF 0-21-0021 The Schiller electrodes are used with the following defibrillators/monitors manufactured by Schiller. Products FRED easy Basic FRED easy ECG on-screen FRED easy Manual FRED AED FRED easyport APLC1 FRED easyport APLC2 AT101 easy Argus Pro Lifecare 1 Argus Pro Lifecare 2
  • Manufacturer
    Schiller

Manufacturer

Schiller