Events

Recall of 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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01088-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-11-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01088-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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...
  • Model / 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
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA