Events

Retiro De Equipo (Recall) de MAQUET HCU 30 Base UnitHeater-Cooler Unit 30 with Serial Number < 93101480HCU 30 Base Unit 100 -120 V, article number 704629 / 70103.4371 HCU 30 base unit 200 -240 V, article number 704631 / 70103.4642 HCU 30 base unit Canadian/US, article number 705501 / 70103.4653

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-2015-RN-01088-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-11-09
  • 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-2015-RN-01088-1
  • 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
    Maquet cardiopulmonary has received complaints associated with a failure of the power supply board of the hcu 30. an internal investigation showed that a drop of more than 10% voltage can cause an overheating and subsequent failing of the ntc (negative temperature coefficient) r56 thermistor of the power supply board. an internal investigation showed that a drop of more than 10% voltage can cause an overheating and subsequent failing of the r56 thermistor of the power supply board of the hcu 30 type 2. a defective r 56 thermistor results in an inoperable compressor, the inability to actively cool the water or an inoperable hcu 30.There are no complaints reported associated with a patient injury or death.
  • Acción
    Users are asked to always keep a replacement unit on standby in order to ensure continuous operation in the event of a complete system failure, whilst the new power supply board which is equipped with a more robust NTC R56 thermistor is being installed. This action has been closed-out on 25/08/2016.

Device

MAQUET HCU 30 Base UnitHeater-Cooler Unit 30 with Serial Number < 93101480HCU 30 Base Unit 100 -1...
  • Modelo / Serial
    MAQUET HCU 30 Base UnitHeater-Cooler Unit 30 with Serial Number < 93101480HCU 30 Base Unit 100 -120 V, article number 704629 / 70103.4371 HCU 30 base unit 200 -240 V, article number 704631 / 70103.4642 HCU 30 base unit Canadian/US, article number 705501 / 70103.4653ARTG Number: 144010
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA