Events

Retiro De Equipo (Recall) de LIFEPAK CR PLUS AED (SEMIAUTOMATIC OPERATION)

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

¿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
    17138
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-10-04
  • 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
    Physio-control has become aware of an issue whereby the lifepak cr plus aed or lifepak expressaed may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. physio-control has determined that there are presently 25178 devices in the field of which approximately 9600 may have this faulty component. a defibrillator in this condition is not delivered and a patient is not resuscitated. all reports received from customers have been noted during initial set up and testing of the device.

Device

LIFEPAK CR PLUS AED (SEMIAUTOMATIC OPERATION)
  • Modelo / Serial
    Model Catalog: 99403-000209 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000280 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000278 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3202359-092 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3202359-019 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3200731-XXX (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3202359-XXX (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99403-000156 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99427-000133 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99427-000129 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80427-000156 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80427-000155 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000279 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000281 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99403-000210 (Lot serial: > 1000
  • Descripción del producto
    LIFEPAK CR Plus (Semi-Automatic);LifepaK CR Express (Semi-Automatic Operation);LIFEPAK CR Express (Semi-Automatic Operation);LIFEPAK CR Plus (Fully Automatic)
  • Manufacturer
    IRIDIA MEDICAL

Manufacturer

IRIDIA MEDICAL
  • Dirección del fabricante
    VANCOUVER
  • Empresa matriz del fabricante (2017)
    Iridia Medical Inc
  • Source
    HC