Events

Retiro De Equipo (Recall) de Sara Combilizer (patient transfer lift)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Huntleigh Healthcare 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-2016-RN-00911-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-11
  • 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-2016-RN-00911-1
  • 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
    It has been identified that a tipping hazard may occur on the current sara combilizer lifting mechanism, resulting in a potential risk to the patient or caregiver. the tipping hazard may occur when fully loaded sara combilizer in “stretcher mode” is lifted to the highest position (approximately 984 mm ˜ 38 3/4”) and tilted backwards to the angle of 25°-28°. this scenario has been defined as highly unlikely to occur during use with patients.
  • Acción
    Huntleigh Healthcare is arranging for an upgrade to the Sara Combilizer that involves the replacement of two parts of the lifting mechanism to ensure the device full stability. In the interim, Huntleigh Healthcare is advising users that the Combilizer can continue to be used until the upgrade is performed, on the condition that the tilt angle in the device "stretcher mode" will be no greater than 15° and the device is not loaded over 330 lbs (150 kg). An Addendum to the Instruction For Use that includes directions to ensure patient safety is also being provided to users. This action has been closed-out on 11/05/2017.

Device

Sara Combilizer (patient transfer lift)
  • Modelo / Serial
    Sara Combilizer (patient transfer lift)Model Number: APA1000 Serial Numbers: P0299662, P0325930, P0325931 & P0325933Manufactured between 16 May 2014 & 17 March 2016ARTG Number: 199602
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA