Events

Retiro De Equipo (Recall) de RAPIDPOINT 500 SYSTEM - MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE 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
    30913
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-09-24
  • 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
    Users can inadvertently enter a wrong patient id on the demographics screen which ultimately could lead to a misidentification of the sample. a patient sample mismatch could be caused by: 1. inadvertently accepting the pre-selected patient id on the demographics screen 2. overwriting sample demographics by incorrect operation of the patient list button 3. scanning the wrong barcode id 4. manually typing in the wrong id in each of these cases failure to check the correct demographics screen before moving on to the results screen will assign the wrong demographics to the sample being tested.

Device

RAPIDPOINT 500 SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: RAPIDPOINT 500 (Lot serial: ); Model Catalog: 10492730 (Lot serial: ); Model Catalog: 1260 (Lot serial: ); Model Catalog: RAPIDPOINT 405 (Lot serial: ); Model Catalog: 05320281 (Lot serial: ); Model Catalog: 1245 (Lot serial: ); Model Catalog: 1265 (Lot serial: ); Model Catalog: 1240 (Lot serial: ); Model Catalog: 129887 (Lot serial: ); Model Catalog: 106444 (Lot serial: ALL S/N FOR ALL DEVICES)
  • Descripción del producto
    RAPIDPOINT 500 SYSTEM-MAIN UNIT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC