Events

Retiro De Equipo (Recall) de Heartsine Pad-Pak/Pedi-Pak Electrode Pack

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Heartsine Technologies Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    16881
  • Fecha de inicio del evento
    2015-04-10
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Amtech Medical Ltd, 281 Heads Road, Wanganui 4501
  • Causa
    During testing at heartsine technologies ltd, an issue has been detected with the seal on the foil pouch which contains the electrodes within the pad-pak and pedi-pak. on a small number, the final seal on the defibrillation electrode pouch was found to be difficult to open. the investigation identified that the supplier of the electrodes to heartsine technologies ltd had made a change to the manufacturing process which meant that an excessive amount of hot melt glue was applied to the final seal of the pouches.
  • Acción
    Product to be returned to supplier

Device

Heartsine Pad-Pak/Pedi-Pak Electrode Pack

Manufacturer

Heartsine Technologies Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA