Events

Recall of HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT VARIOUS VOLTAGES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

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
    30584
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 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. 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.

Device

HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT VARIOUS VOLTAGES
  • Model / Serial
    Model Catalog: 00939001 (Lot serial: > 10 numbers contact mfg); Model Catalog: 00705501 (Lot serial: > 10 numbers contact mfg); Model Catalog: 0704629 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC