Events

Notificaciones De Seguridad De Campo acerca de Kryo range of freezers

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Planer PLV.

¿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
    Field Safety Notice
  • Número del evento
    SN2014(23)
  • Fecha
    2014-05-06
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/kryo-range-of-freezers.-priority-2-warning&id=7acef925-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    Should the temperature probe to the chamber fail in a short circuit condition, the temperature will appear to be too cold, and the controller will attempt to compensate by warming the samples. although this behaviour is the expected response of the control system, two software changes have been released to improve the resilience of the freezer systems to temperature probe faults. planer has released new versions of the pid engine firmware, pp007951 v6.85 and the mrv main application, cfg007954 v5.22.
  • Acción
    The IMB advise that users:  (1) Follow the instructions outlined by the manufacturer in the field safety notice (FSN) attached.  (2) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information. Please also pass this Safety Notice and the attached FSN on to any end users or organisations where these devices may have been distributed.

Device

Kryo range of freezers
  • Modelo / Serial
  • Descripción del producto
    Kryo range of freezers
  • Manufacturer
    Planer PLV

Manufacturer

Planer PLV
  • Empresa matriz del fabricante (2017)
    Planer Plc
  • Source
    HPRA