Events

Retiro De Equipo (Recall) de PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-00040-2
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-01-18
  • 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-00040-2
  • 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
    A quality issue has been identified, relating to an incorrect power status indication with the ps900 power module supplied with the affected patient monitoring products. the products with the defective power module installed can generate false "battery low" alarms, and may have an incorrect power status shown on the screen.The battery cannot be used in its current state as it cannot be recharged. however, the products can continue to be used the by plugging them into main power.
  • Acción
    The sponsor is advising users that the affected devices can continue to be used provided that they are connected to a main power. The sponsor will contact the affected users to arrange for a firmware upgrade and/or the replacement of the power module. This action has been closed-out on 16/05/2017.

Device

PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors
  • Modelo / Serial
    PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors Product code: ED-SE-1200E-BSerial numbers of the monitors affected:60531-M1590102000160531-M1590102000260531-M1590102000360531-M1590102000560531-M1590102000960531-M1590454000260531-M1590454000311076-M1590453000111076-M1590453000211076-M1590453000311076-M1590453000411076-M15904530005ARTG Numbers: 178086 and 236697
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd