Events

Retiro De Equipo (Recall) de Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare 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-2013-RN-01234-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-26
  • 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-2013-RN-01234-1
  • 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 spring inside the mounting latch can become dislodged causing the pdm not to latch properly resulting in an unexpected loss of patient monitoring function. this may also result in the pdm falling onto a patient or caregiver. warning messages are displayed indicating patient parameters which have been disconnected and also, a three short burst alarm is issued and repeated if acknowledged.
  • Acción
    GE Healthcare is advising users to refrain from mounting the monitor above a patient or caregiver and refrain from mounting the monitor at a downward facing angle. GE Healthcare will be installing a new latch on all units once available. This action has been closed-out on 10/02/2016.

Device

Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifun...
  • Modelo / Serial
    Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module)Product Codes: SA3, SG5All monitors produced from April 2007 to December 2012.Serial Numbers: SA030713XXXXXX to SA31252XXXXXX and SG050713XXXXXX to SG51252XXXXXXARTG Number: 118982
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd