Events

Recall of Maquet HCU30 Heater Cooler Unit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Maquet Cardiopulmonary AG.

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
    19356
  • Event Initiated Date
    2015-11-06
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • 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. this failure typically occurs when the compressor is switched on, i.E. before patient connection. a defective thermistor results in an inoperable compressor or in an inoperable hcu 30. there are no complaints reported associated with a patient injury or death.
  • Action
    Product to be modified

Device

Maquet HCU30 Heater Cooler Unit
  • Model / Serial
    Model: Article Number 704631 / 70103.4642, Affected: Selected serial numbers
  • Manufacturer
    Maquet Cardiopulmonary AG

Manufacturer

Maquet Cardiopulmonary AG
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA