Events

Retiro De Equipo (Recall) de Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilities

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ulco Engineering 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-2014-RN-01172-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-30
  • 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-01172-1
  • 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
    Mindray has identified the following issues:- the 12-lead standard and extended measurement report will include false measurements when the p wave or qrs axis cannot be accurately determined by the algorithm. - the median complex and extended measurement report will display the representative beat as 25% larger than actual signal input. - when a patient date of birth is imported into the v-series from an external source, such as mindray’s gateway, e-gateway, panorama central station or panorama workstation, the age will not pass into the 12-lead ecg interpretation algorithm. the algorithm analysis will use the default adult criteria of “50 year adult” in which case the interpretive statements may be incorrect, depending on the actual age of the patient. any output of the 12-lead ecg interpretation data (e.G. printed records, ecg management system, etc.) will include the issues described above. there have been no reports of injuries associated with these issues.
  • Acción
    Mindray is recommending that users discontinue use of the affected units until the software correction is completed. This action has been closed-out on 26/08/2016.

Device

Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilities
  • Modelo / Serial
    Mindray V-Series Patient Monitors with 12-lead ECG interpretation capabilitiesV-series Model Numbers: 1409 & 1410Serial Numbers: EGD16006409, EGD13004678 & EGD0B002460ARTG Numbers: 223384
  • Manufacturer
    Ulco Engineering Pty Ltd

Manufacturer

Ulco Engineering Pty Ltd
  • Source
    DHTGA