Events

Retiro De Equipo (Recall) de Molift Air 205 and 300 ceiling hoist (a powered lifting device)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Patient Handling 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-00975-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-25
  • 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-00975-1
  • 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
    The manufacturer has received a total of 4 reports where the bolt on the suspension coupling on molift air has become loose in the coupling. all reports came after technical testing and inspection. to date, no reports have been received regarding patient injury resulting from this issue. however, there is a potential risk for harm or injury if the bolt inside the coupling comes loose from the housing.
  • Acción
    Patient Handling will arrange to upgrade the device with a retainer safety ring that will prevent the bolt within the suspension coupling coming loose. Qualified service personnel will install the upgrade kits on all affected systems. Consumers are advised to contact the place of purchase to organise a qualified service technician to install the upgrade kit. For more details, please see https://www.tga.gov.au/alert/molift-air-ceiling-hoist .

Device

Molift Air 205 and 300 ceiling hoist (a powered lifting device)
  • Modelo / Serial
    Molift Air 205 and 300 ceiling hoist (a powered lifting device)Molift Air 205Model Numbers: 2501205, 2501210, 2501215, 2501220Molift Air 300Model Numbers: 2501300, 2501310, 2501315, 2501320Distributed between May 2013 and January 2016ARTG Number: 229696
  • Manufacturer
    Patient Handling Pty Ltd

Manufacturer

Patient Handling Pty Ltd