Events

Retiro De Equipo (Recall) de HAMILTON G5 / S1 ICU ventilators Software versions 2.00X up to 2.31X

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AHC Solutions Pty Ltd.

¿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-00556-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-29
  • 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-00556-1
  • 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 maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult). this vulnerability of the hamilton-g5 and hamilton-s1 exists within an interference-prone time window of 50 milliseconds after the ventilator detects a disconnection during a suctioning maneuver that has been initiated by the operator pressing the o2-enrichment key on the ventilator.
  • Acción
    AHC Solutions is advising operators to always verify that ventilation continues after a suctioning manoeuvre. If ventilation does not continue it can be re-established by pressing the "Manual Breath" key, change the ventilation mode and switch to the "Stand-by Mode" and return to the previously used ventilation mode. AHC Solutionsis advising customer to permanently disable the automated suctioning manoeuvre on all affected ventilators using the software key provided with the customer letter to avoid the issue from occurring. This action has been closed-out on 29/01/2016.

Device

HAMILTON G5 / S1 ICU ventilators Software versions 2.00X up to 2.31X
  • Modelo / Serial
    HAMILTON G5 / S1 ICU ventilatorsSoftware versions 2.00X up to 2.31X
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd