Events

Retiro De Equipo (Recall) de PROPAQ LT MONITOR WITH WIRELESS RADIO

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por WELCH ALLYN CANADA LIMITED.

¿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
    43160
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-11-01
  • 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
    Fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could in rare instances potentially interrupt propaq lt device operations. if this unlikely event were to occur the device would either present an error screen instructing the user to restart the monitor or could instead present a blank or white screen. either screen would be accompanied by one or more blinking led lights and in either case the issue would be resolved by restarting (power cycling) the monitor. there is no risk associated with this issue other than a very short delay in obtaining patient vital signs from the propaq lt while the device is restarted.

Device

PROPAQ LT MONITOR WITH WIRELESS RADIO
  • Modelo / Serial
    Model Catalog: 802LTAN (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 802LT0N (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 802LTRN (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Descripción del producto
    PROPAQ LT 802LTAN
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED