Events

Retiro De Equipo (Recall) de BladderScan BVI 9600 with AortaScan mode portable ultrasound instrument

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Verathon Medical 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-2015-RN-01212-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-12-11
  • 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-2015-RN-01212-1
  • 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 device is currently indicated for obtaining an image of the abdominal aorta for aortic diameter measurement. due to the design characteristics, the abdominal aortic measurement (aaa) reported by the device may be significantly smaller (or larger) than the actual diameter of the abdominal aorta. the devices can measure abdominal aortic diameters ranging from 3 to 12.4 cm with a diameter accuracy of ± 15% ± 0.5 cm. for example, a true abdominal aortic diameter of 5.3 cm may be reported to be as low as 4.01 cm or as large as 6.60 cm. in another example, a true abdominal aortic diameter of 3.5 cm may be reported to be as low as 2.48 cm or as large as 4.53 cm.Serious injuries and/or deaths could occur due to the failure mode associated with the issue. verathon have received a report of one (1) serious injury due to this issue.
  • Acción
    The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of AAAs. Because of the potential variation in measurement and the serious health risks associated with undetected AAAs, Verathon is reminding users that, if clinically indicated, appropriate patients should be referred for a diagnostic standard test for either screening for or diagnosis of an AAA regardless of test results obtained with BladderScan BVI 9600 device. This action has been closed-out on 24/08/2016.

Device

BladderScan BVI 9600 with AortaScan mode portable ultrasound instrument

Manufacturer

Verathon Medical Australia Pty Ltd