Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Philips Healthcare.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 002 12 14 000
  • Fecha de inicio del evento
    2014-12-01
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6794
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Issue 1: the mrx can be susceptible to interference from electrical fast transients (efts) when connected to ac or dc power, operating with a lan cable, or operating near a source of eft interference, which could cause therapy to be delayed or delivered inadvertently. issue 2: if a user performs either of the following two atypical clinical workflows, the mrx can exhibit unexpected behavior. these workflows do not correspond to instructions in the mrx instructions for use (ifu) and are not expected to be performed by trained clinicians. in addition, these device behaviors have only been observed during internal testing, and have not been reported during clinical use. the workflows and associated device behaviors are as follows: ( please find attached to see them ) issue 3: the mrx could stop demand mode pacing due to an ecg leads-off condition when electrode-to-skin contact impedance values are outside design ranges for detection. note: philips has previously improved the mrx’s ability to maintain ecg monitoring in the presence of high skin contact impedance. however, these improvements are not available on devices with revision b.06.Xx software.

Device

HeartStart MRx monitor/defibrillators
  • Modelo / Serial
    Product: Philips HeartStart MRx Monitor/Defibrillators Units Affected: MRx units with a serial number within the following ranges: Model M3535A: US00100100 to US00576623 Model M3536A: US00100902 to US00576650 Model M3536J: US00209838 to US00332675 Model M3536M: US00500002 to US00553553 Model M3536MC: US00500001 to US00500087 Model M3536M2: US00554176, US00554177, US00554178 Model M3536M4: US00500003 to US00574869 Model M3536M5: US00500001 to US00562935 Model M3536M6: US00554358 to US00576619
  • Descripción del producto
    Defibrillator/Pacemakers, External
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Representante del fabricante
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA