Events

Retiro De Equipo (Recall) de HEARTSTART MRX DEFIBRILLATOR/MONITOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS 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
    155048
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-11-07
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Philips has become aware of three (3) issues that could impact the safety and/or performance of certain mrx monitor/defibrillators: issue 1: the heartstart mrx defibrillator/monitor 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 one of two atypical clinical workflows the heartstart mrx defibrillator/monitor can exhibit unexpected behaviour. these workflows do not correspond to instructions in the heartstart mrx defibrillator/monitor instructions for use and are not expected to be performed by trained clinicians. in addition these device behaviours have only been observed during internal testing and have not been reported during clinical use. the workflows and associated device behaviors are as follows: workflow a: when using external paddles for defibrillation the device can deliver a shock when only one of the two shock buttons are depressed if the user performs a specific sequence. workflow b: when using the periodic clinical data transmission (pcdt) option on the mrx the mrx can reboot if the user performs a specific sequence. issue 3: the heartstart mrx defibrillator/monitor 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.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Modelo / Serial
    Model Catalog: M3535A (Lot serial: ALL); Model Catalog: M3536A (Lot serial: ALL)
  • Descripción del producto
    HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC