Events

Retiro De Equipo (Recall) de Surveyor S12 and Surveyor S19 Patient MonitorsMultiple part numbers and serial numbers affected

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mortara Instrument 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-2014-RN-01108-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-17
  • 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-01108-1
  • 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
    Mortara instrument, inc. has recently become aware of a potential safety hazard involving surveyor s12 and surveyor s19 patient monitors. a hazardous situation may be created when mounting these monitors using the 75mm vesa mounting hole pattern provided in the battery cover of these monitors. if the mounting screws provided by mortara are not used and if the mounting screws used are longer than the provided screws, it is possible for the longer screws to be driven completely through the battery cover and then possibly penetrate the protective casing of the lithium-ion battery which may result in a fire. there have been no reported incidents of fire, injury or death due to this potential safety hazard. a correction has been developed to eliminate the potential risk. thecorrection alters the design of the battery cover, creating a barrier that prevents mounting screws from penetrating into the battery compartment.
  • Acción
    A Mortara Instrument Australia service representative will be contacting affected customers to schedule an update that includes replacement of the battery cover and replacement of the battery pack if mounting screw damage is evident. This update is at no cost to the customer. This action has been closed-out on 1/03/2016.

Device

Surveyor S12 and Surveyor S19 Patient MonitorsMultiple part numbers and serial numbers affected
  • Modelo / Serial
    Surveyor S12 and Surveyor S19 Patient MonitorsMultiple part numbers and serial numbers affectedManufactured March, 2012 to September, 2014ARTG Number: 215421
  • Manufacturer
    Mortara Instrument Australia Pty Ltd

Manufacturer

Mortara Instrument Australia Pty Ltd