Events

Retiro De Equipo (Recall) de Hamilton Medical C3 Ventilator

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-2017-RN-01174-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-28
  • 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-2017-RN-01174-1
  • 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
    Taleb medical has received a customer complaint relating an issue relating to the battery charge of the hamilton-c2/c3 batteries after a usage of two and a half years. an analysis has identified that after two and a half years, the battery fuel gauge may indicate a higher battery charge as to what is actually available. the technical failure 444001 ”low battery” high priority alarms are triggered, alerting the operator both acoustically and visually before entering ambient mode.When batteries are depleted, the operator is alerted by high priority alarms and if the ventilator is not immediately connected to an ac power outlet, the ventilator will switch into ambient mode.
  • Acción
    1. The operator or service personnel should make themselves familiar with the batteries’ date of installation and manufacturing date and react in time if the battery is more than two years in operation or maximum three years from the manufacturing date. 2. The battery’s manufacture date is engraved on the top of the battery connector (see supplied letter for details). a. Any battery in operation for more than two years prior to the actual date should be replaced. b. If the battery is less than two years old attach a label stating the manufacturing date or the commissioning date of the battery (if known) manually on the battery or the ventilator which contains this battery and check it periodically against the current date. c. Slide the battery back into slot until it clicks and close the battery door. 3. Complete and the supplied customer acknowledgement form and return to Taleb, 4. Taleb will arrange for the replacement of affected batteries.

Device

Hamilton Medical C3 Ventilator

Manufacturer

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