Events

Retiro De Equipo (Recall) de V5Ms transesophageal transducer (used for ultrasound imaging)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens 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-2014-RN-00943-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-08-29
  • 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-2014-RN-00943-1
  • 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
    Seiemens has received recent overseas reports about the deterioration of material covering the articulating section of the v5ms transesophogeal transducer. although to date, no patient injury has been reported, a compromise or fault in this material combined with a failure to use a probe cover as directed in the user manual may cause oesophageal cuts, bleeding, and perforation to the patient, and severe trauma, electrical burns, and serious electrical hazards to the patient and the user. however, a leakage current test can indicate cracks, cuts, tears, perforations, and protrusions in the articulation material.
  • Acción
    To avoid the potential risk associated with this issue, customers are asked to undertake the following steps: - Perform the leakage current test for a transesophageal transducer prior to each use. - Use only Siemens approved cleaning and disinfecting solutions. - Use market-cleared transducer sheaths specifically designed for TEE applications. - When users store the transesophageal transducer, take extreme care that the distal tip is straight. Never move the distal tip by hand. Always use the flex controls. Customers are advised that if they notice any damage or wear on the transducer, or if the transducer fails to pass the leakage current test, immediately discontinue use of the transducer and contact their local Customer Service Engineer. This action has been closed-out on 06/06/2016.

Device

V5Ms transesophageal transducer (used for ultrasound imaging)
  • Modelo / Serial
    V5Ms transesophageal transducer (used for ultrasound imaging)Catalogue numbers: 08263703 and 8264577Serial number range: 32800000 to 42300000 (manufactured 2013-2014)ARTG number: 186302
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA