Events

Retiro De Equipo (Recall) de VITAL SIGNS 300 SERIES NIBP MONITOR W/PULSE RATE/MAP AND PRINTER

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
    44082
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-07-09
  • 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
    Speakers in vsm300 vital signs monitor failed to produce sound. the failure of the speaker eliminates audio alarm tones for parameter violation equipment alerts or error codes as well as repetitive beeps to indicate pulses when monitoring sp02 (oximetry).

Device

VITAL SIGNS 300 SERIES NIBP MONITOR W/PULSE RATE/MAP AND PRINTER
  • Modelo / Serial
    Model Catalog: 5300P-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530T0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530T0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5300P-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53000-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53000-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1R (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530TP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530TP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N0P-F1 (Lot serial:
  • Descripción del producto
    VITAL-SIGNS MONITOR W/RATE/MAP PRINTER
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED