Events

Retiro De Equipo (Recall) de PURITAN BENNETT 980 SERIES VENTILATOR - VENTILATOR

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

¿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
    28967
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-01-19
  • 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
    During a gui transient reset the primary display becomes blank for approximately 30 seconds. it is important to note that the ventilator continues to provide full respiratory support. during that short period high-priority audio and visual alarms are activated and the secondary status display provides the operator key ventilator status data and states "display failed" "ventilating as set" and "replace ventilator". after the reset cycle completes the gui display refreshes the alarms are terminated and the ventilator continues full operation.

Device

PURITAN BENNETT 980 SERIES VENTILATOR - VENTILATOR
  • Modelo / Serial
    Model Catalog: 980S1ENDICU (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 980U1ENDICU (Lot serial: ALL SERIAL NUMBERS)
  • Descripción del producto
    PURITAN BENNETT 980 SERIES VENTILATOR
  • Manufacturer
    COVIDIEN LLC

Manufacturer

COVIDIEN LLC
  • Dirección del fabricante
    MANSFIELD
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC