Events

Retiro De Equipo (Recall) de A.T.S. 2200 and A.T.S. 4000 Tourniquet Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Zimmer Biomet 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-2017-RN-01068-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-08-16
  • 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-01068-1
  • 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
    Zimmer biomet has received a total of 14 complaints that the ats 2200 spontaneously inflates the secondary cuff without any user input. zimmer biomet is providing an on-device label and an updated operator/service manual. a medical device corrective action for the ats 2200 and ats 4000 tourniquet systems is being implemented utilising a shortened separation distance of 1.0 metre between rf communication equipment, in order to mitigate the potential for electromagnetic interference and achieve optimal performance of the tourniquet machines.There have been no injuries or deaths reported to date as a result of this issue.
  • Acción
    Zimmer is requesting that customers: 1.Review the notification and ensure affected personnel are aware of the contents; 2.Confirm the receipt of the on-device label and 3 pages of the updated Operator/Service Manual provided with the customer letter; 3.Place the label on the device in the specified location; 4.Replace the 3 pages of the Operator/Service Manual with the updated pages; and 5.Email a completed copy of the supplied Attachment 1 form to RAQA.ANZ@Zimmerbiomet.com to confirm that they have placed the label in the specified location on the device and replaced the 3 pages of the Operator/Service Manual with the updated pages.

Device

A.T.S. 2200 and A.T.S. 4000 Tourniquet Systems
  • Modelo / Serial
    A.T.S. 2200 and A.T.S. 4000 Tourniquet SystemsATS2200TS with hosesItem Number: 60-2200-101-00Serial Number (prefix only): 2214-2216ATS4000TS with hosesItem Number: 60-4000-101-00Serial Number (prefix only): 4014-4016ARTG Number: 95696
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet Pty Ltd
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA