Events

Retiro De Equipo (Recall) de SLE 5000 Ventilator

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AHC Solutions 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-00855-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-08-23
  • 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-00855-1
  • 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 manufacturer has identified a potential risk associated with the fp110-410 psu (power supply unit). their internal monitoring and investigations have identified a suspect batch of electrolytic capacitors used on the main pcb (printed circuit board) of the 410 power supply unit. the affected capacitors may exhibit a swelling that if not replaced, may in time cause the ventilator to shut down during normal operation. please note that should the ventilator shut down, a total power fail alarm will sound.
  • Acción
    AHC Solutions is advising users to identify ventilators with serial numbers below 53164 and, using the instructions provided, identify ventilators with Power Supply Units with serial numbers between 163746 to 167558 for replacement.

Device

SLE 5000 Ventilator
  • Modelo / Serial
    SLE 5000 VentilatorVentilator model SLE 5000: Serial numbers below 53164Power supply unit model FP110-410: Serial numbers 163746 to 167558 inclusiveARTG Number: 114000
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd