Events

Retiro De Equipo (Recall) de Hamilton Medical G5 / S1 Ventilator, software versions between V2.00 and V2.31

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia.

¿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
    RC-2014-RN-00557-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-28
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00557-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Investigations have shown that ventilation and alarms of a hamilton g5 or hamilton s1 ventilator can be suppressed unintentionally after the activation of a suctioning manoeuvre by the operator. this situation can occur regardless of the selected patient group (neonatal, paediatric, & adult). this vulnerability of the hamilton –g5 and hamilton –s1 exists under specific conditions within an interface prone time window of 50 milliseconds after the ventilator detects a disconnection during a suctioning manoeuvre that has been initiated by operator pressing the o2-enrichment key on the ventilator. this issue could result in the termination of mechanical ventilation and suppression of alarms with the exception of the medium-priority alarm “loss of peep” when peep is set > 4 mbar. please note that the ambient and exhalation valves of the ventilator are opened so that a spontaneously breathing patient can breathe room air unassisted by the ventilator.
  • Acción
    Permanently disable the automated suctioning manoeuvre functionality on all Hamilton G5/ Hamilton S1 ventilators by using a software key provided by the manufacturer. This correction will be undertaken during the preventative maintenance due in June/July 2014. Thia action has been closed-out on 28/01/2016

Device

Hamilton Medical G5 / S1 Ventilator, software versions between V2.00 and V2.31

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia