Events

Retiro De Equipo (Recall) de Philips HeartStart MRx or XL+ monitor/defibrillator

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 Philips Medical Systems (USA).

¿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
    21703
  • Fecha de inicio del evento
    2017-07-21
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    When a monitor/defibrillator is receiving an ecg signal from an auxiliary bedside monitor via a sync cable or ecg out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (efts):, " on the heartstart mrx and heartstart xl, eft noise may be misinterpreted as an r-wave., " on the heartstart xl+, eft noise can disable ecg monitoring and potentially interrupt demand mode pacing.
  • Acción
    Product to be returned to supplier

Device

Philips HeartStart MRx or XL+ monitor/defibrillator
  • Modelo / Serial
    Model: , Affected: sync cables, models M1783A and M5526A, and ECG out cables, model 989803195641.
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA