Events

Retiro De Equipo (Recall) de Zero-Gravity Radiation Protection System (overhead suspended radiation protection shield) Zero-Gravity ceiling mounted monorail with hinged swing arm, Zero-Gravity floor unit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Biotronik Australia 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-01289-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-29
  • 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-2016-RN-01289-1
  • 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 zero-gravity radiation protection system achieves its nearly weightless support of the body shield by employing a steel cable attached to a balancer. two reports from users of the system suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. while no injuries or deaths occurred in either failure, the zero-gravity body shield weighs 25 kg, and in the event of a cable failure, the body shield will fall immediately. a fall of this nature places the user, associated staff and the patient at risk for a potentially serious injury.
  • Acción
    Biotronik will be contacting users and arranging for the replacement of the cable. In addition, the instructions for use and protocols will be updated to include a step to allow the cable to unwind after each use. In the interim, users should inspect the cable for signs of wear or rotational tension that may have created a bend or buckle in the cable. Also, users should review their routine use of the Zero-Gravity Radiation Protection System to determine if the body shield undergoes repeated rotation without allowing the cable to relax back to its normal condition. If the cable has been consistently rotated in one direction without being allowed to relax back to its normal condition or if there is any doubt about excessive rotation in one direction, it is recommended that use is discontinued until the cable is replaced. If facilities continue to use the System until the cable is replaced, they should make sure that they are allowing the unit to go back to its relaxed state. This action has been closed-out on 25/05/2017.

Device

Zero-Gravity Radiation Protection System (overhead suspended radiation protection shield) Zero-Gr...
  • Modelo / Serial
    Zero-Gravity Radiation Protection System (overhead suspended radiation protection shield)Zero-Gravity ceiling mounted monorail with hinged swing armCatalogue Number: 412766TIDI Part Number: ZGCM-HSASerial Number: 582023Zero-Gravity floor unitCatalogue Number: 403803TIDI Part Number: ZGM-6.5HSerial Number: 549772Supplied and installed between 28 June 2010 and 31 August 2016ARTG Number: 221225
  • Manufacturer
    Biotronik Australia Pty Ltd

Manufacturer

Biotronik Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Ms Holding Ii Se
  • Comentario del fabricante
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    DHTGA