Events

Retiro De Equipo (Recall) de DASH 4000 PATIENT MONITOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    106164
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-01-18
  • 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
    Ge healthcare became aware of the following issues affecting dash 3000/4000/5000 patient monitors and dash port 2. dash 3000/4000/5000 patient monitors: 1. dash stops communicating on the unity network resulting in loss of monitoring at the carescapet cic pro central station* 2. dash displays distorted ecg waveforms in combination monitoring mode 3. dash incorrectly becomes time master on the unity network 4. dash date reverts to 1993 dash port 2: 5. dash port 2 stops communicating on the unity network resulting in loss of monitoring at the carescapet cic pro central station* *despite communication loss the dash 3000/4000/5000 will continue to provide bedside monitoring including alarms and event storage.

Device

DASH 4000 PATIENT MONITOR
  • Modelo / Serial
    Model Catalog: DASH4-XXXX-XXXX-XXXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: DASH5-XXXX-XXXX-XXXX (Lot serial: >10 lot numbers contact mfg); Model Catalog: 2041850-002 (Lot serial: >10 lot numbers contact mfg); Model Catalog: DASH3-XXXX-XXXX-XXXX (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    DASH 4000 PATIENT MONITOR
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)